Clinical Research & Trials

*A151216 ALCHEMIST Screening Protocol

Lead Researcher: Yuhchyau Chen

This ALCHEMIST trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient's tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

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*NRG-CC009 / CRLUN22012 / Milano

Lead Researcher: Michael Milano

This phase III trial compares the effect of stereotactic radiosurgery to standard of care memantine and whole brain radiation therapy that avoids the hippocampus (the memory zone of the brain) for the treatment of small cell lung cancer that has spread to the brain. Stereotactic radiosurgery is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may cause less damage to normal tissue. Whole brain radiation therapy delivers a low dose of radiation to the entire brain including the normal brain tissue. Hippocampal avoidance during whole-brain radiation therapy (HA-WBRT) decreases the amount of radiation that is delivered to the hippocampus which is a brain structure that is important for memory. The drug, memantine, is also often given with whole brain radiotherapy because it may decrease the risk of side effects related to thinking and memory. Stereotactic radiosurgery may decrease side effects related to memory and thinking compared to standard of care HA-WBRT plus memantine.

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*NRG-GU011 PROMETHEAN / RGUP21115 / Zhang

Lead Researcher: Hong Zhang

This phase II trial tests whether relugolix and radiation therapy works to shrink tumors in patients with prostate cancer that has spread in a limited way to 1 to 5 other parts of the body (oligometastatic). Testosterone can cause the growth of prostate cancer cells. Relugolix lowers the amount of testosterone made by the body. This may help stop the growth of tumor cells that need testosterone to grow. Giving relugolix with radiation therapy may help lower the chance of prostate cancer growing or spreading.

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*RTOG 1216 / RHAN13055 / Surgery and Postoperative Radiation / Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

This phase II/III trial studies how well radiation therapy works when given together with cisplatin, docetaxel, cetuximab, and/or atezolizumab after surgery in treating patients with high-risk stage III-IV head and neck cancer the begins in the thin, flat cells (squamous cell). Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Cetuximab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. The purpose of this study is to compare the usual treatment (radiation therapy with cisplatin chemotherapy) to using radiation therapy with docetaxel and cetuximab chemotherapy, and using the usual treatment plus an immunotherapy drug, atezolizumab.

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A022101 ERASur / CRGIC23031 / Alliance / QIU

Lead Researcher: Haoming Qiu

This phase III trial compares total ablative therapy and usual systemic therapy to usual systemic therapy alone in treating patients with colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (IV) (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. Ablative means that the intention of the local treatment is to eliminate the cancer at that metastatic site. The ablative local therapy will consist of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR) with or without surgical resection and/or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. SABR, surgical resection, and microwave ablation have been tested for safety, but it is not scientifically proven that the addition of these treatments are beneficial for your stage of cancer. The addition of ablative local therapy to all known metastatic sites to the usual approach of systemic therapy could shrink or remove the tumor(s) or prevent the tumor(s) from returning.

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A041703 / CLEU19006 / O'Dwyer, Kristen

Lead Researcher: Kristen O'Dwyer

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back, or does not respond to treatment. Immunotherapy with monoclonal antibodies, such as inotuzumab ozogamicin and blinatumomab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

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A081801 / RLUN20119 / ALCHEMIST-IO (ACCIO) / Yuhchyau Chen

Lead Researcher: Yuhchyau Chen

This phase III ALCHEMIST trial tests the addition of pembrolizumab to usual chemotherapy for the treatment of stage IIA, IIB, IIIA or IIIB non-small cell lung cancer that has been removed by surgery. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as cisplatin, pemetrexed, carboplatin, gemcitabine hydrochloride, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab with usual chemotherapy may help increase survival times in patients with stage IIA, IIB, IIIA or IIIB non-small cell lung cancer.

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Adapting CBT-I for Hazardous Alcohol Users

Lead Researcher: Wilfred Pigeon

The goal of this intervention development trial is to develop, refine, and test a telephone-delivered, 4-session version of cognitive behavioral therapy for insomnia adapted to hazardous alcohol users with co-occurring insomnia. The project will begin with a small, open label pilot to refine the intervention and proceed to a small, randomized trial comparing the intervention to a sleep and alcohol education control condition. The two main questions it aims to answer are whether the intervention is feasible to deliver and whether its effects on alcohol use and insomnia severity are large enough to warrant further work.

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ADVANCED-2

Lead Researcher: William Tabayoyong

TARA-002-101-Ph2 is an open-label study to investigate the safety and anti-tumor activity of intravesical instillation of TARA-002 in adults 18 years of age or older with high-grade CIS NMIBC (± Ta/T1). The purpose of this Phase 2 study (TARA-002-101-Ph2) is to further assess the safety and anti-tumor activity of TARA-002 at the RP2D which has been established in the Phase 1a dose finding study (TARA-002-101-Ph1a). This Phase 2 study includes participants with CIS NMIBC (± Ta/T1) with active disease (defined as disease present at last tumor evaluation prior to signing ICF). Participants will be enrolled into one of 2 cohorts: Cohort A: * Participants with CIS (± Ta/T1) who are BCG naive, or * Participants with CIS (± Ta/T1) who are BCG exposed and have not received intravesical BCG for at least 24 months prior to the most recent CIS diagnosis Cohort B: * Participants with persistent or recurrent CIS (± Ta/T1) who are BCG unresponsive within 12 months of completion of adequate BCG therapy (minimum 5/6 doses induction and 2/3 doses maintenance or 2/6 doses reinduction)

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Algo TX/IOCPC23007/ Gewandter

Lead Researcher: Jennifer Gewandter

The purpose of this clinical trial is to compare the efficacy of twice daily applications of ATX01 (10% \& 15%) versus placebo during a 12-week treatment period in treating chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer survivor patients.

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An EEG Study of Auditory Perception in People with and without Schizophrenia

Lead Researcher: Judy Thompson

The purpose of our study is to better understand how the brain processes sounds, including speech. We are investigating this in people with and without psychiatric conditions. One of our primary aims is to determine how these processes may relate to specific experiences and symptoms in conditions such as schizophrenia, schizoaffective disorder, and schizophreniform disorder, with the goal of using this knowledge to develop more effective treatments. In order to study how the brain processes sounds, we use a technique called electroencephalography, or EEG. For EEG, a person wears a comfortable elastic cap with sensors attached to it that are able to record brain activity. In these sessions, subjects listen to short audio clips while EEG is recording; this allows us to measure brain responses to sounds. This study also includes interviews about current and past psychiatric symptoms and treatment, as well as a few short tasks, questionnaires, and a hearing test. The study typically involves 4-5 visits, with each about 2-3 hours long. Subjects are paid $30 an hour, as well as a $30 bonus if they complete all study activities. Transportation costs are also covered, and free snacks are provided. People between the ages of 18-55 with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or no psychiatric diagnosis may be eligible to participate.

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Assessment of Patients with Brain Tumors, Ages 65+

Lead Researcher: Andrea Wasilewski

The purpose of this study is to collect information about the physical function, thinking, independence, social support, and medications of older patients with brain tumors in order to develop more specialized treatments and support for that population. Inclusion Criteria: Age 65 or older of any race, ethnicity, or gender; Pathologically confirmed glioblastoma or anaplastic astrocytoma; Have not started radiation or chemotherapy for brain tumor treatment

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Atorvastatin Study in HNSCC/UHAN21082/Newlands

Lead Researcher: Shawn Newlands

Background: Cisplatin is used to treat head and neck cancer. People who take this drug are at risk for hearing loss. Atorvastatin is a drug used to treat high cholesterol. It might reduce the risk of cisplatin-induced hearing loss. Objective: To find out if atorvastatin reduces hearing loss in people treated with cisplatin and radiation. Eligibility: People ages 18 and older with squamous cell carcinoma of the head and neck who will undergo treatment with cisplatin-based chemotherapy and radiation Design: Participants will be screened with their medical records. Participants currently taking a cholesterol-lowering statin medication are invited to participate in the observational arm of the study. Those not taking such a medication are invited to participate in the interventional arm of the study. All participants will have 3 study visits for the purpose of evaluating hearing. One before starting cisplatin treatment, one within 3 months of completing cancer treatment, and one within 2 years of completing cancer treatment. They will have tympanograms. A small flexible tip will be placed in the ear canal. A puff of air will be delivered to assess mobility of the ear drum. They will have hearing tests. They will wear headphones. They will listen to tones that vary in loudness. They will be asked to indicate when they hear a sound. They will complete 3 questionnaires at the time of each hearing test. Participants will have 2 visits for blood tests. These will occur upon consent and 12 weeks after. They will be randomly assigned to take the study drug or placebo orally, once daily. They will take it during cisplatin treatment and for 3 months after treatment. Long-term follow up will include a chart review 2 years after participants complete their cisplatin therapy.

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BABE

Lead Researcher: Kirsi Jarvinen-seppo

You are eligible if you are pregnant and 18 years old or older and give birth to a healthy infant. The purpose of this study is to compare a group of people at low risk for getting allergies, the Old Order Mennonite, with a group of people at higher risk of getting allergies, the average person living in Rochester. The immune system protects us from diseases, working throughout the body, including in secretions such as saliva and breast milk, and in the normal bacteria in the stomach and intestines. The way people live, including the things they are exposed to, changes the way the immune system develops. A baby’s immune system develops over time. The baby’s ability to fight disease is helped by the mom’s immunity passed to the baby through breast milk. By comparing biological samples like saliva, breast milk, and stool, we can study differences between these two groups to see what’s different in a group at low risk and a group at higher risk of getting allergies. Using questionnaires and biologic samples (stool, skin cells, blood, etc.) we will evaluate the development of the infant microbiome, metabolite composition and the immune system and how that relates to the development of allergic disease. The microbiome is the collection of all microbes, such as bacteria, fungi, viruses, and their genes, that naturally live on our bodies and inside us. A metabolite is any substance produced during metabolism (digestion or other bodily chemical processes). The term metabolite may also refer to the product that remains after a medicine is broken down (metabolized) by the body.

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BEGIN - A Breastfeeding Study

Lead Researcher: Bridget Young

We are looking for: - Mothers who are exclusively pumping for babies under 5 weeks old - Participation will last until your baby is 5 months old - We will have you collect breastmilk, stool, urine, and saliva at home - This study is totally remote – no need to ever leave your house! Earn $100/month & receive breastfeeding support from our team!

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CBMT11074 / NMDP 10-CBA / Omar Aljitawi, MBBS (previous PI-Jane Liesveld, MD)

Lead Researcher: Omar Aljitawi

This study is an access and distribution protocol for unlicensed cryopreserved cord blood units (CBUs) in pediatric and adult patients with hematologic malignancies and other indications.

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CBRS21001 / A011801 / Dhakal

Lead Researcher: Ajay Dhakal

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

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CBRT20074 / A071701 / NImish Mohile

Lead Researcher: Nimish Mohile

This phase II trial studies how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, PI3K, or KRAS G12C. Medications that target these genes such as abemaciclib, paxalisib, entrectinib and adagrasib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation.

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CCTG-MA.39 TAILOR RT / CRBRS23092 / Gergelis

Lead Researcher: Kimberly Gergelis

The purpose of this study is to compare the effects on low risk breast cancer receiving usual care that includes regional radiation therapy, with receiving no regional radiation therapy. Researchers want to see if not giving this type of radiation treatment works as well at preventing breast cancer from coming back.

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Cedars - Sinai - Gross Hematuria - UGUB23025

Lead Researcher: Edward Messing

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with gross hematuria.

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CGIP20087 / A021806 / Richard Dunne

Lead Researcher: Daniel Mulkerin

This phase III trial compares perioperative chemotherapy (given before and after surgery) versus adjuvant chemotherapy (given after surgery) for the treatment of pancreatic cancer that can be removed by surgery (removable/resectable). Chemotherapy drugs, such as fluorouracil, irinotecan, leucovorin, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy before and after surgery (perioperatively) may work better in treating patients with pancreatic cancer compared to giving chemotherapy after surgery (adjuvantly).

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CGUK20147 / S1931 / Frye

Lead Researcher: Thomas Frye

This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Axitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Surgery to remove the kidney, called a nephrectomy, is also considered standard of care; however, doctors who treat kidney cancer do not agree on its benefits. It is not yet known if the addition of surgery to an immunotherapy-based drug combination works better than an immunotherapy-based drug combination alone in treating patients with kidney cancer.

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CGUP18150 / S1802 / Chunkit Fung

Lead Researcher: Chunkit Fung

This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

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CGYM19142 / NRG-GY019 / Richard Moore

Lead Researcher: Richard Moore

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving letrozole alone or in combination with paclitaxel and carboplatin works better in treating patients with low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum compared to paclitaxel and carboplatin without letrozole.

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CGYO20085 / NRG-CC008 / Richard Moore

Lead Researcher: Richard Moore

This clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.

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CHAN21104 / NRG-HN009 / Patel

Lead Researcher: Arpan Patel

This phase II/III trial compares the effect of the combination of high-dose cisplatin every three weeks and radiation therapy versus low-dose cisplatin weekly and radiation therapy for the treatment of patients with locoregionally advanced head and neck cancer. Chemotherapy drugs, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. This study is being done to find out if low-dose cisplatin given weekly together with radiation therapy is the same or better than high-dose cisplatin given every 3 weeks together with radiation therapy in treating patients with head and neck cancer.

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CLEU20105/ S1905/ Kristen O'Dwyer

Lead Researcher: Kristen O'Dwyer

This phase II trial studies how well OBI-3424 works in treating patients with T-cell acute lymphoblastic leukemia that has come back (relapsed) or does not response to treatment (refractory). Drugs used in chemotherapy, such as OBI-3424, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. OBI-3424 may reduce the amount of leukemia in the body.

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CLEU20136 / EA9181 / O'Dwyer

Lead Researcher: Kristen O'Dwyer

This phase III trial compares the effect of usual treatment of chemotherapy and steroids and a tyrosine kinase inhibitor (TKI) to the same treatment plus blinatumomab. Blinatumomab is a Bi-specific T-Cell Engager ('BiTE') that may interfere with the ability of cancer cells to grow and spread. The information gained from this study may help researchers determine if combination therapy with steroids, TKIs, and blinatumomab work better than the standard of care.

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CLUN19026 / LUNGMAP / Megan Baumgart

Lead Researcher: Megan Baumgart

This screening and multi-sub-study randomized phase II/III trial will establish a method for genomic screening of similar large cancer populations followed by assigning and accruing simultaneously to a multi-sub-study hybrid Master Protocol (Lung-MAP). The type of cancer trait (biomarker) will determine to which sub-study, within this protocol, a participant will be assigned to compare new targeted cancer therapy, designed to block the growth and spread of cancer, or combinations to standard of care therapy with the ultimate goal of being able to approve new targeted therapies in this setting. In addition, the protocol includes non-match sub-studies which will include all screened patients not eligible for any of the biomarker-driven sub-studies.

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CLUN21035 / S1900E / Baumgart

Lead Researcher: Megan Baumgart

This phase II Lung-MAP treatment trial studies the effect of AMG 510 in treating non-squamous non-small cell lung cancer that is stage IV or has come back (recurrent) and has a specific mutation in the KRAS gene, known as KRAS G12C. Mutations in this gene may cause the cancer to grow. AMG 510, a targeted treatment against the KRAS G12C mutation, may help stop the growth of tumor cells.

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CLYM20151 / S1925 / Barr

Lead Researcher: Paul Barr

This phase III trial compares early treatment with venetoclax and obinutuzumab versus delayed treatment with venetoclax and obinutuzumab in patients with newly diagnosed high-risk chronic lymphocytic leukemia or small lymphocytic lymphoma. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Immunotherapy with monoclonal antibodies, such as obinutuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with the venetoclax and obinutuzumab early (before patients have symptoms) may have better outcomes for patients with chronic lymphocytic leukemia or small lymphocytic lymphoma compared to starting treatment with the venetoclax and obinutuzumab after patients show symptoms.

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CLYM21071 / S2005 / Zent

Lead Researcher: Clive Zent

This phase II trial studies the effects of venetoclax and rituximab in comparison to ibrutinib and rituximab in treating patients with previously untreated Waldenstrom's macroglobulinemia/lymphoplasmacytic lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving venetoclax and rituximab may work better in treating patients with previously untreated Waldenstrom's macroglobulinemia than ibrutinib and rituximab alone.

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CLYM21085 / A051902 / Casulo

Lead Researcher: Carla Casulo

This phase II trial studies the effect of duvelisib or CC-486 and usual chemotherapy consisting of cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisone in treating patients with peripheral T-cell lymphoma. Duvelisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as CC-486, cyclophosphamide, doxorubicin, vincristine, etoposide and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help find out if this approach is better or worse than the usual approach for treating peripheral T-cell lymphoma.

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CLYM21088 / ANHL1931 / Casulo

Lead Researcher: Carla Casulo

This phase III trial compares the effects of nivolumab with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.

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CMBRS23057 / Weiss / A012103

Lead Researcher: Anna Weiss

The phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

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CMBRS24006 / Falkson / NRG-BR009

Lead Researcher: Carla Falkson

This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

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CMGIC22093 // A022104 // BADRI

Lead Researcher: Nabeel Badri

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

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CMGIC23011 // NRG-GI008 // McGreevy

Lead Researcher: Maria McGreevy

This Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.

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CMGUB24000 // A031701 // GUERCIO

Lead Researcher: Brendan Guercio

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

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CMGYN23039_Moore_NRG-GY025

Lead Researcher: Richard Moore

This phase II trial tests whether the combination of nivolumab and ipilimumab is better than nivolumab alone to shrink tumors in patients with deficient mismatch repair system (dMMR) endometrial carcinoma that has come back after a period of time during which the cancer could not be detected (recurrent). Deoxyribonucleic acid (DNA) mismatch repair (MMR) is a system for recognizing and repairing damaged DNA. In 2-3% of endometrial cancers this may be due to a hereditary condition resulted from gene mutation called Lynch Syndrome (previously called hereditary nonpolyposis colorectal cancer or HNPCC). MMR deficient cells usually have many DNA mutations. Tumors that have evidence of mismatch repair deficiency tend to be more sensitive to immunotherapy. There is some evidence that nivolumab with ipilimumab can shrink or stabilize cancers with deficient mismatch repair system. However, it is not known whether this will happen in endometrial cancer; therefore, this study is designed to answer that question. Monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving nivolumab in combination with ipilimumab may be better than nivolumab alone in treating dMMR recurrent endometrial carcinoma.

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CMLEU23033 // A042001 // O'Dwyer

Lead Researcher: Kristen O'Dwyer

This phase II trial compares the combination of inotuzumab ozogamicin and chemotherapy to the usual chemotherapy in treating patients with B-cell acute lymphoblastic leukemia or B-cell lymphoblastic lymphoma. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a drug, called CalichDMH. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers CalichDMH to kill them. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving inotuzumab ozogamicin with chemotherapy may help shrink the cancer and stop it from returning.

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CMLUN23010 // S2302 // MULFORD

Lead Researcher: Deborah Mulford

This phase III trial compares the effect of the combination of ramucirumab and pembrolizumab versus standard of care chemotherapy for the treatment of non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial may help doctors find out if giving ramucirumab with pembrolizumab is more effective at treating patients with stage IV or recurrent non-small cell lung cancer than standard chemotherapy.

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CMLUN24013 // EA5221 // Baumgart

Lead Researcher: Megan Baumgart

This phase III trial compares the effect of adding chemotherapy to immunotherapy (pembrolizumab) versus immunotherapy alone in treating patients with stage IIIB-IV lung cancer. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving pembrolizumab and chemotherapy may help stabilize lung cancer.

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CMLYM23020 // S2114 // Reagan

Lead Researcher: Patrick Reagan

This phase II trial tests whether mosunetuzumab and/or polatuzumab vedotin helps benefit patients who have received chemotherapy (fludarabine and cyclophosphamide) followed by chimeric antigen receptor (CAR) T-cell therapy (tisagenlecleucel, axicabtagene ciloleucel, or lisocabtagene maraleucel) for diffuse large B-cell lymphoma that has come back (recurrent) or that does not respond to treatment (refractory) or grade IIIb follicular lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, called polatuzumab, linked to a drug called vedotin. Polatuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, and delivers vedotin to kill them. Chemotherapy drugs, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Giving mosunetuzumab and/or polatuzumab vedotin after chemotherapy and CAR T-cell therapy may be more effective at controlling or shrinking the cancer than not giving them.

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CMLYM23030 // AHOD2131 // Casulo

Lead Researcher: Carla Casulo

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

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CMLYM23075 // A052101 // Wallace

Lead Researcher: Danielle Wallace

This phase III trial tests whether continuous or intermittent zanubrutinib after achieving a complete remission (CR) with rituximab works in older adult patients with mantle cell lymphoma (MCL) who have not received treatment in the past (previously untreated). Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Zanubrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. When zanubrutinib is used in MCL, the current standard of care is to continue administering the drug indefinitely until disease progression. This continuous treatment comes with clinical as well as financial toxicity, which could be especially detrimental in older patients. For patients who achieve a CR after initial zanubrutinib plus rituximab therapy, it may be safe and equally effective to stop treatment and restart zanubrutinib upon disease progression rather than continuing indefinitely in previously untreated older adult patients with MCL.

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CMMEL22099_Galka_S2015

Lead Researcher: Eva Galka

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

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CMMMY23044 // S2209 // Lipe

Lead Researcher: Brea Lipe

This phase III trial compares three-drug induction regimens followed by double-or single-drug maintenance therapy for the treatment of newly diagnosed multiple myeloma in patients who are not receiving a stem cell transplant and are considered frail or intermediate-fit based on age, comorbidities, and functional status. Treatment for multiple myeloma includes initial treatment (induction) which is the first treatment a patient receives for cancer followed by ongoing treatment (maintenance) which is given after initial treatment to help keep the cancer from coming back. There are three combinations of four different drugs being studied. Bortezomib is one of the drugs that may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Lenalidomide works by helping bone marrow to produce normal blood cells and killing cancer cells. Anti-inflammatory drugs, such as dexamethasone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Daratumumab and hyaluronidase-fihj is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Patients receive 1 of 3 combinations of these drugs for treatment to determine which combination of study drugs works better to shrink and control multiple myeloma.

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CMMY19113 / S1803 / Brea Lipe

Lead Researcher: Brea Lipe

Patients are enrolled to screening (Reg Step 1) prior to or after ASCT but prior to Reg Step 2. Patients are followed until they will begin Maintenance and then registered to Reg Step 2 (first randomization). Patients are randomized between Lenalidomide for 2 years and Lenalidomide + Daratumumab/rHuPH20. After 2 years of Maintenance, MRD is assessed to guide further therapy. MRD-positive patients will continue with the assigned treatment. MRD-negative patients will be further randomized (Reg Step 3) to either continue or discontinue the assigned treatment. Patients are treated for up to 7 years from Step 2 reg and followed for up to 15 years.

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CMSAR23088 // EA7211 // Victor

Lead Researcher: Adrienne Victor

This is a multicenter, randomized, open label phase lll trial to assess whether preoperative chemotherapy, as an adjunct to curative-intent surgery, improves the prognosis of high risk DDLPS (dedifferentiated Liposarcoma) and LMS (Leiomyosarcoma) patients as measured by disease free survival. After confirmation of eligibility criteria, patients will be randomized to either the standard arm or experimental arm.

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Connection in Caregivers

Lead Researcher: Kimberly Van orden

Subjects will complete a baseline interview (phone/zoom and online) at the beginning of the study. If eligible, subjects will complete 10 days of surveys that are texted 3 times a day (morning, afternoon, evening). Eligible subjects will also complete a follow-up interview (zoom/phone and online) at 6 months. Subjects are paid up to $400 for completing assessments. Inclusion: age 50 and older; caring daily for a loved one with dementia; caregiving stress. Exclusion: Under 50 years of age; not caring for a loved one with dementia daily.

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COVID-19 Vaccine Studies

Lead Researcher: Ann Falsey

URMC is studying several variations of a COVID-19 vaccine. Compensation: $500-$900. Participation Requirements: Age 18+; Have not been infected with COVID-19. To volunteer, take our survey to find out if you qualify: https://redcap.urmc.rochester.edu/redcap/surveys/?s=XHH9MC8RMK

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CPLEU23006 // ASCT2031 // Andolina

Lead Researcher: Jeffrey Andolina

This phase III trial compares hematopoietic (stem) cell transplantation (HCT) using mismatched related donors (haploidentical \[haplo\]) versus matched unrelated donors (MUD) in treating children, adolescents, and young adults with acute leukemia or myelodysplastic syndrome (MDS). HCT is considered standard of care treatment for patients with high-risk acute leukemia and MDS. In HCT, patients are given very high doses of chemotherapy and/or radiation therapy, which is intended to kill cancer cells that may be resistant to more standard doses of chemotherapy; unfortunately, this also destroys the normal cells in the bone marrow, including stem cells. After the treatment, patients must have a healthy supply of stem cells reintroduced or transplanted. The transplanted cells then reestablish the blood cell production process in the bone marrow. The healthy stem cells may come from the blood or bone marrow of a related or unrelated donor. If patients do not have a matched related donor, doctors do not know what the next best donor choice is. This trial may help researchers understand whether a haplo related donor or a MUD HCT for children with acute leukemia or MDS is better or if there is no difference at all.

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CPSAR23078 / Kazi / ARST2032

Lead Researcher: Rafi Kazi

Rhabdomyosarcoma is a type of cancer that occurs in the soft tissues in the body. This phase III trial aims to maintain excellent outcomes in patients with very low risk rhabdomyosarcoma (VLR-RMS) while decreasing the burden of therapy using treatment with 24 weeks of vincristine and dactinomycin (VA) and examines the use of centralized molecular risk stratification in the treatment of rhabdomyosarcoma. Another aim of the study it to find out how well patients with low risk rhabdomyosarcoma (LR-RMS) respond to standard chemotherapy when patients with VLR-RMS and patients who have rhabdomyosarcoma with DNA mutations get separate treatment. Finally, this study examines the effect of therapy intensification in patients who have RMS cancer with DNA mutations to see if their outcomes can be improved.

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Developing a collection of clinical, imaging and biologic specimens to identify biological markers of Parkinson’s risk, onset and progression

Lead Researcher: Ruth Schneider

The Parkinson Progression Marker Initiative 2.0 (PPMI 2.0) is a longitudinal, observational, multi-center natural history study to assess progression of clinical features, digital outcomes, and imaging, biologic and genetic markers of Parkinson's disease (PD) progression in study participants with manifest PD, prodromal PD, and healthy controls. The overall goal of the study is to identify markers of disease progression for use in clinical trials of therapies to reduce progression of PD disability.

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DRO2005 / RHAN20083 / ALTENS / Michael Cummings

Lead Researcher: Michael Cummings

The purpose of this study would like to learn if acupuncture-like electrical therapy can be used in patients with head and neck cancer who have had radiation treatment to treat dry mouth.

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DRO72835 / ULUN18075 / Lung 3 vs 5 Fx SBRT / Deepinder Singh

Lead Researcher: Deepinder Singh

This study's goal is to find out if the kind of side effects people experience from radiation is different depending on the schedule of their radiation treatment. Patients will be randomly assigned to either the 3 Fraction or 5 Fraction schedule of radiation. After patients complete radiation treatment, they will follow up with their radiation oncologist.

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Efficacy and Safety of Seralutinib in Adult Subjects With PAH (PROSERA)

Lead Researcher: R White

Seralutinib is an inhaled medication for PAH. Participants with PAH age 18-75 and a BMI of 17-40 may be eligible to participate. Participants will be randomized to either placebo or drug. The duration of the study is up to a maximum of 48 weeks.

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EN21-PP/01 Painful Diabetic peripheral Neuropathy Study

Lead Researcher: Mark Williams

The University of Rochester is looking for adults 18 years and older with feet pain from diabetes to participate in a research study about a new investigational medication. We want to find out if it can treat foot pain from diabetes. If you are eligible, you will be asked to: (1) come to 7 visits in our clinic over 7 months, (2) take the study medication each day, and (3) answer surveys. You will be paid $85 for each completed visit. Study related examinations and study medication will be provided at no cost.

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Fine Eye Movement Study

Lead Researcher: Brian Keane

This study will look at differences in eye movement as they relate to visual perception and the way people think. The information collected in this study will aid in finding ways to more accurately diagnose psychiatric disorders, namely schizophrenia, by using eye scans. Also, results from this study may guide the development of more tailored therapies to help people with psychiatric disorders in the future. Procedures include: interviews about your medical and drug use history; a vocabulary test; review of your eRecord data; visual perceptual tasks completed on a computer; and eye scans (like those during an eye doctor exam). Some of these procedures may occur via Zoom, depending on participant preferences. Eligibility: Ages 18-55; a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder OR no psychiatric disorder with no more than one lifetime major depressive episode.

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Future Contact Database for People with Asthma

Lead Researcher: Steve Georas

The doctors and researchers in the Pulmonary and Critical Care Medicine Division at the University of Rochester are creating a database (a list) of individuals with asthma who are interested in taking part in future research studies about asthma. If you are contacted, you can decide at that time whether or not you are interested in participating in that study. You may be contacted via telephone, mail, or email. Being included in the database does not mean that you will be enrolled in that study; rather, you are only agreeing to be contacted about future research studies. You are eligible to join if you are 18 years of age or older, have an asthma diagnosis, and are willing to answer brief questionnaires about your medical history and medication use.

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GEMS/Mustian/URCC19178

Lead Researcher: Karen Mustian

This phase III cluster randomized trial compares the effect of geriatric evaluation and management with survivorship health education (GEMS) to usual care on patient-reported physical function in older survivors of cancer. Survivorship care for older adults of cancer usually consists of getting advice from their doctor. This advice may include how to do their daily activities, so they are less tired or how to manage multiple diseases, or long-term side effects from treatment. GEMS may help improve the physical ability to perform activities of daily living, mental well-being, and memory in older survivors of cancer after chemotherapy. This study may help doctors learn if including GEMS in their practices improves physical, mental and memory functions in their patients. The study may also help to understand how such care affects cancer patients and their caregivers' quality of life.

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HEROES Study - Health Effects (Renal) Of Extra Strength Avmacol

Lead Researcher: Thu Le

This study will determine if taking a daily broccoli supplement (Avmacol ES) can decrease kidney disease progression rate and inflammation in patients with Chronic Kidney Disease (CKD). The study will enroll 100 patients from the Kidney Clinic in AC3 and Highland Hospital who have CKD stages 3-4.

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Hydrocortisone for premature babies

Lead Researcher: Carl D'angio

The Hydrocortisone and Extubation study will test if giving hydrocortisone for 10 days improves survival for premature infants who have a breathing tube. Infants will either receive hydrocortisone or placebo.

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IBRS19007 / FLEX Registry / Ajay Dhakal

Lead Researcher: Ajay Dhakal

The FLEX Registry will be implemented to operate as a large-scale, population based, prospective registry. All patients with stage I to III breast cancer who receive MammaPrint® and BluePrint testing on a primary breast tumor are eligible for entry into the FLEX Registry, which is intended to enable additional study arms at low incremental effort and cost. FLEX Registry will utilize an adaptive design, where additional targeted substudies and arms can be added after the initial study is opened.

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ILYM20053 / KT-US-499-0150 / Reagan

Lead Researcher: Patrick Reagan

The goal of this clinical study is to learn more about the safety and dosing of the study drugs, KITE-363 and KITE-753, in participants with relapsed and/or refractory B-cell lymphoma.

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ILYM21068 / EONHL1-20 / Friedberg

Lead Researcher: Jonathan Friedberg

The purpose of this study is to define the recommended Phase 2 Dose, safety, tolerability, immunogenicity, and preliminary efficacy of EO2463 during monotherapy and in combination with lenalidomide and/or rituximab in patients with indolent NHL

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IMBRS22048_Dhakal_Celcuity CELC-G-301 Gedatolisib

Lead Researcher: Ajay Dhakal

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

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IMBRS23027_Falkson_J2J-MC-JZLH - EMBER-4

Lead Researcher: Carla Falkson

The main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. Study participation could last up to 10 years.

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IMLT21110 // KT-US-982-5968 // Reagan

Lead Researcher: Patrick Reagan

The goal of this clinical study is to learn more about the long-term safety, effectiveness and prolonged action of Kite study drugs, axicabtagene ciloleucel, brexucabtagene autoleucel, KITE-222, KITE-363, KITE-439, KITE-585, and KITE-718, in participants of Kite-sponsored interventional studies.

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IMLYM22090 // M23-647 // Barr

Lead Researcher: Paul Barr

Non-Hodgkin's lymphoma (NHL) is a cancer that arises from the transformation of normal B and T lymphocytes (white blood cells). The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) non-Hodgkin's lymphomas: third line or later of treatment (3L) + chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large b-cell lymphoma (DLBCL), non-germinal center B cell (GCB) DLBCL, mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL), Waldenström macroglobulinemia (WM), or transformed indolent NHL. Adverse events will be assessed. ABBV-101 is an investigational drug being developed for the treatment of NHL. This study will include a dose escalation phase to determine the maximum administered dose (MAD)/Maximum tolerated dose (MTD) of ABBV-101 and a dose expansion phase to determine the change in disease activity in participants with CLL or non-GCB DLBCL. Approximately 128 adult participants with multiple NHL subtypes will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating oral doses of ABBV-101, until the MAD/MTD is determined, as part of the approximately 60 month study duration. In the dose expansion phase of the study participants receive oral ABBV-101, as part of the approximately 60 month study duration . There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, and side effects.

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IMMEL22088_Sahasrabudhe_R3767-ONC-2055

Lead Researcher: Deepak Sahasrabudhe

This study is researching an experimental drug called REGN3767, also known as fianlimab (R3767), when combined with another medication called cemiplimab (each individually called a "study drug" or called "study drugs" when combined) compared with an approved medication called pembrolizumab. The objective of this study is to see if the combination of fianlimab and cemiplimab is an effective treatment compared to pembrolizumab in patients that have had melanoma removal surgery but are still at high risk for the recurrence of the disease. Pembrolizumab is an approved treatment in some countries in this clinical setting. The study is looking at several other research questions, including: * What side effects may happen from receiving the study drugs. * How much study drug is in the blood at different times. * Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects). Antibodies are proteins that are naturally found in the blood stream that fight infections. * How administering the study drugs might improve quality of life.

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IMMLT23021 // ACR-368-201 (GOG 3082) // Guercio

Lead Researcher: Brendan Guercio

This is an open label Phase 1b/2 study to evaluate the efficacy and safety of ACR-368 as monotherapy or in combination with ultralow dose gemcitabine in participants with platinum-resistant ovarian carcinoma, endometrial adenocarcinoma, and urothelial carcinoma based on Acrivon's OncoSignature® test status.

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IMMY20144/ 64407564MMY1001/ Brea Lipe

Lead Researcher: Brea Lipe

The purpose of this study is to evaluate the efficacy and safety of talquetamab in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose(s) (RP2Ds) (Part 3).

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Intellectual & Developmental Disabilities Research Center Contact Registry

Lead Researcher: Alexander Paciorkowski

The University of Rochester's Intellectual & Developmental Disabilities Research Center (IDDRC) is creating a research study contact database for those with intellectual and developmental disabilities (IDDs). This will help keep people with IDDs, and their families, informed about opportunities to join research studies that can impact the way healthcare is provided, improving the health and wellbeing of those with IDDs. When you join this contact database, you may be contacted about future research study opportunities at the University of Rochester. There are a variety of studies that may be offered, and some studies may offer compensation. There is no obligation to participate in any of the future studies for which you are contacted. You can always withdraw from a research study at any time without penalty. If you have an IDD diagnosis, you can sign up to be a part of this database (it’s okay for a legal guardian to help with the sign-up if needed). Qualifying diagnoses include, but are not limited to, autism spectrum disorders, developmental delay, intellectual disability, Down syndrome, fetal alcohol spectrum disorder, cerebral palsy, MECP2 mutation (e.g., Rett Syndrome), Batten disease and Angelman syndrome, as well as epilepsy/seizure conditions, tuberous sclerosis and movement disorders with a corresponding IDD.

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Interactive Group Drumming and "Chemo Brain"

Lead Researcher: Gaelen Mccormick

If you decide to take part in this study, you will be asked to participate, as you are able, in four consecutive weekly drumming groups of up to ten people occurring at the same time each week, led by a professional facilitator. Each group will be one hour in length. During these groups, the facilitator will invite subjects to follow simple oral (singing and speaking) and musical instructions by playing the drums we will provide. At the beginning and the end of each session, you will be asked to answer a brief questionnaire about your state of wellbeing. At the beginning and end of the study, you will be asked to answer a survey about cognitive function (and your experience with “chemo brain”) using the FACT COG assessment survey. After the study concludes, you will be asked to answer a survey about satisfaction with your experience of the drumming session. Your participation will last about 4 weeks.

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IPNEU22061 / DAY101-002 / Korones

Lead Researcher: David Korones

This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of tovorafenib monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.

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IPNEU23016 // ONC201-108 // Korones

Lead Researcher: David Korones

This is a randomized, double-blind, placebo-controlled, parallel-group, international, Phase 3 study in patients with newly diagnosed H3 K27M-mutant diffuse glioma to assess whether treatment with ONC201 following frontline radiotherapy will extend overall survival and progression-free survival in this population. Eligible participants will have histologically diagnosed H3 K27M-mutant diffuse glioma and have completed standard frontline radiotherapy.

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ISCR2201MN (Nucleix)

Lead Researcher: Michael Nead

This study is part of the development and validation of a non-invasive lung screening test which aim to identify early stage lung cancer in patients at high risk for lung cancer.

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Longitudinal Subtyping Of Atopic Dermatitis Through Skin Analysis

Lead Researcher: Lisa Beck

This is a study which will characterize the gene expression profiles that underlie mild and moderate-severe Atopic dermatitis (AD). It will determine changes in these expression patterns in response to standard-of-care treatment. Participants will complete up to ten study visits with assessment of topical steroid response and dupilumab response (if uncontrolled with topical steroids). Skin samples will be collected at all study visits to determine the gene expression profiles that underlie mild vs. moderate-severe atopic dermatitis. Healthy participants without atopic dermatitis will serve as a control population and must agree to apply a topical moisturizer (Vanicream) at least twice daily for 7 days. Atopic dermatitis patients must have chronic AD with active lesions.

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Lymphoma & Leukemia: Collection of specimens and epidemiological and clinical outcomes data in patients with hematological malignancies

Lead Researcher: Walter Burack

This research is being done because we hope that a better understanding of hematologic malignancies will allow us to develop new and better treatments.

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Measuring Surgical Recovery After Radical Cystectomy

The intent of this study is to establish a registry of post‐surgical outcomes in patients undergoing radical cystectomy. The goals of this initiative are to obtain a detailed baseline of multiple patient‐reported outcomes (PRO) and clinician‐reported outcomes (CRO) as well as various presenting conditions associated with them, so that future quality improvement interventions can be evaluated accurately as to their relative contribution to improved outcomes.

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Music training for concerts for people with hearing aids or cochlear implants

Lead Researcher: Gaelen Mccormick

This is a study of a novel music-listening training intervention. Half the subjects will be randomly assigned to the music listening training modules intervention and the remaining subjects will be assigned to the waitlist control (offered the intervention upon study completion). All subjects will: (1) attend two 45- to 60-minute concerts held at the Eastman School of Music, approximately 10 to 12 weeks apart; (2) complete 2 questionnaires directly following the concerts about their music listening habits, preferred music genres, and issues associated with attending concerts. Between the two concerts, individuals in the intervention arm will be provided 15-minute training sessions as podcasts that subjects can listen to twice a week for 8 weeks (16 podcasts) at times and places of their choosing.

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NRG-BN012 / CRNEU23065 / Milano

Lead Researcher: Michael Milano

This phase III trial compares the addition of stereotactic radiosurgery before or after surgery in treating patients with cancer that has spread to the brain (brain metastases). Stereotactic radiosurgery is a type of radiation therapy that delivers a high dose of radiation only to the small areas of cancer in the brain and avoids the surrounding normal brain tissue. Surgery and radiation may stop the tumor from growing for a few months or longer and may reduce symptoms of brain metastases.

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NRG-BR008 HERO / CRBRS23022 / Gergelis

Lead Researcher: Kimberly Gergelis

This Phase III trial compares the recurrence-free interval (RFI) among patients with early-stage, low risk HER2+ breast cancer who undergo breast conserving surgery and receive HER2-directed therapy, and are randomized to not receive adjuvant breast radiotherapy versus those who are randomized to receive adjuvant radiotherapy per the standard of care.

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NRG-GU008 / RGUP20037 / INNOVATE / Hong Zhang

Lead Researcher: Hong Zhang

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. Radiation therapy uses high energy x-ray to kill tumor cells and shrink tumors. Androgens, or male sex hormones, can cause the growth of prostate cancer cells. Drugs, such as apalutamide, may help stop or reduce the growth of prostate cancer cell growth by blocking the attachment of androgen to its receptors on cancer cells, a mechanism similar to stopping the entrance of a key into its lock. Adding apalutamide to the usual hormone therapy and radiation therapy after surgery may stabilize prostate cancer and prevent it from spreading and extend time without disease spreading compared to the usual approach.

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NRG-GU009 / RGUP21002 / PREDICT-RT / Kevin Bylund

Lead Researcher: Kevin Bylund

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score. Apalutamide may help fight prostate cancer by blocking the use of androgen by the tumor cells. Radiation therapy uses high energy rays to kill tumor cells and shrink tumors. Giving a shorter hormone therapy treatment may work the same at controlling prostate cancer compared to the usual 24 month hormone therapy treatment in patients with low gene risk score. Adding apalutamide to the usual treatment may increase the length of time without prostate cancer spreading as compared to the usual treatment in patients with high gene risk score.

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NRG-GU010 / RGUP21107 / GUIDANCE / Michael Cummings

Lead Researcher: Michael Cummings

This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy). Radiation therapy uses high energy x-rays or particles to kill tumor cells and shrink tumors. Androgen deprivation therapy blocks the production or interferes with the action of male sex hormones such as testosterone, which plays a role in prostate cancer development. Giving radiation treatment alone may be the same as the usual approach in controlling the cancer and preventing it from spreading, while avoiding the side effects associated with hormonal therapy. In patients with higher Decipher gene risk, this trial compares the addition of darolutamide to usual treatment radiation therapy and hormone therapy, to usual treatment. Darolutamide blocks the actions of the androgens (e.g. testosterone) in the tumor cells and in the body. The addition of darolutamide to the usual treatment may better control the cancer and prevent it from spreading.

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NRG-LU008 / CRLUN23043 / NRG / SINGH

Lead Researcher: Deepinder Singh

This phase III trial compares the effect of adding stereotactic body radiation therapy (SBRT) to standard treatment (image guided radiation therapy \[IGRT\] and chemotherapy followed by immunotherapy with durvalumab) versus standard treatment alone in treating patients with non-small cell lung cancer that cannot be treated by surgery (inoperable). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. IGRT is a type of radiation that uses a computer to create picture of the tumor, to help guide the radiation beam during therapy, making it more accurate and causing less damage to healthy tissue. Standard chemotherapy used in this trial consists of combinations of the following drugs: cisplatin, carboplatin, paclitaxel, pemetrexed, and etoposide. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Paclitaxel is in a class of medications called antimicrotubule agents. It works by stopping the growth and spread of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by blocking the action of a certain substance in the body that may help tumor cells multiply. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill tumor cells. Immunotherapy with durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Adding SBRT to the standard treatment of IGRT with chemotherapy and immunotherapy may be more effective at treating patients with inoperable non-small cell lung cancer than giving the standard treatment alone.

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Observational Study of ICU Patients with Systemic Inflammatory Response Syndrome (SIRS)

Lead Researcher: Anthony Pietropaoli

This is an observational research study of subjects admitted to the ICU with severe SIRS (and/or sepsis). For ICU subjects enrolled: the study involves collecting up to 2 blood samples (3-5 days apart), data collection, and post-discharge follow-up questionnaires. For healthy volunteers: Subjects age 65 and older are needed for a one-time blood sample collection for comparison studies. A brief health questionnaire and set of vital signs will also be collected at the study visit. Volunteers must be age 65 or older and cannot be on antibiotics or antivirals for current infection. Volunteers also must not have had an infection within 6 weeks prior to the study visit.

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Outcome Disparities in Adolescents with Acute Lymphoclastic Leukemia (ALL)

Lead Researcher: Kristen O'Dwyer

We will establish two prospective groups of patients with Acute Lymphoclastic Leukemia (ALL): "Cohort A" will be enrolled on the study at the time of diagnosis while "Cohort B" will be enrolled during maintenance chemotherapy.

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Parent Cafe Study for Caregivers of Children with Medical Complexity

Lead Researcher: Nathaniel Bayer

We started monthly peer and emotional support group sessions for caregivers of children with medical complexity. We are looking for interested parents and caregivers to participate in our research, attend support sessions, and provide feedback to improve them. A child with medical complexity means that a child has/had 2 or more long-term diagnoses and uses/used medical devices (like a feeding tube or tracheostomy). Depending on the status and age of your child, you could either help us design the support groups, lead the support groups, or participate in the support groups as an attendee. Families with different diagnoses, outcomes, racial and ethnic backgrounds, genders, sexual orientations, religions, geographic regions and physical abilities all provide important insight and perspective. We are recruiting caregivers of children who have fully recovered, have recovered with ongoing needs, are undergoing treatment, or have passed away. Your lived experience and perspective matters.

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PASSAGE: Effectiveness of Tezepelumab, an Injectable Medication, in Treating Severe Asthma

Lead Researcher: Steve Georas

Adult and adolescent participants may be eligible if they have severe asthma with 2 or more exacerbations in the last 12 months. The study consists of 15 in-person visits (1 to 3 hours each). Visit 1 will be for eligibility screening. The study drug, tezepelumab, will be given at visits 2-14. Visit 15 will be for follow-up examination.

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PBRT20077 / ACNS1831 / Korones

Lead Researcher: David Korones

This phase III trial studies if selumetinib works just as well as the standard treatment with carboplatin/vincristine (CV) for subjects with NF1-associated low grade glioma (LGG), and to see if selumetinib is better than CV in improving vision in subjects with LGG of the optic pathway (vision nerves). Selumetinib is a drug that works by blocking some enzymes that low-grade glioma tumor cells need for their growth. This results in killing tumor cells. Drugs used as chemotherapy, such as carboplatin and vincristine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether selumetinib works better in treating patients with NF1-associated low-grade glioma compared to standard therapy with carboplatin and vincristine.

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PCCO15102 / APEC14B1 / EveryChild Protocol / Kazi

Lead Researcher: Rafi Kazi

This study gathers health information for the Project: Every Child for younger patients with cancer. Gathering health information over time from younger patients with cancer may help doctors find better methods of treatment and on-going care.

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PGUK06001 / AREN03B2 / Kazi

Lead Researcher: Rafi Kazi

This research trial studies kidney tumors in younger patients. Collecting and storing samples of tumor tissue, blood, and urine from patients with cancer to study in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

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PHEM15022 / PIDTC-6901 / Jeffrey Andolina

Lead Researcher: Jeffrey Andolina

This study is a prospective evaluation of children with Severe Combined Immune Deficiency (SCID) who are treated under a variety of protocols used by participating institutions. In order to determine the patient, recipient and transplant-related variables that are most important in determining outcome, study investigators will uniformly collect pre-, post- and peri-transplant (or other treatment) information on all children enrolled into this study. Children will be divided into three strata: * Stratum A: Typical SCID with virtual absence of autologous T cells and poor T cell function * Stratum B: Atypical SCID (leaky SCID, Omenn syndrome and reticular dysgenesis with limited T cell diversity or number and reduced function), and * Stratum C: ADA deficient SCID and XSCID patients receiving alternative therapy including PEG-ADA ERT or gene therapy. Each Group/Cohort Stratum will be analyzed separately.

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PHEM15023 / PIDTC-6903 / Jeffrey Andolina

Lead Researcher: Jeffrey Andolina

Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone marrow transplantation (BMT) has been shown to be curative. However the risks of transplantation are high and not all patients with CGD may need to undergo this high risk procedure. This study will determine the long term medical condition and daily functioning of participants with CGD after a transplant and if possible, compare these results to participants who do not undergo a transplant.

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PLEU19175 / AALL1732 / Kazi

Lead Researcher: Rafi Kazi

This phase III trial studies whether inotuzumab ozogamicin added to post-induction chemotherapy for patients with High-Risk B-cell Acute Lymphoblastic Leukemia (B-ALL) improves outcomes. This trial also studies the outcomes of patients with mixed phenotype acute leukemia (MPAL), and B-lymphoblastic lymphoma (B-LLy) when treated with ALL therapy without inotuzumab ozogamicin. Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a type of chemotherapy called calicheamicin. Inotuzumab attaches to cancer cells in a targeted way and delivers calicheamicin to kill them. Other drugs used in the chemotherapy regimen, such as cyclophosphamide, cytarabine, dexamethasone, doxorubicin, daunorubicin, methotrexate, leucovorin, mercaptopurine, prednisone, thioguanine, vincristine, and pegaspargase or calaspargase pegol work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. This trial will also study the outcomes of patients with mixed phenotype acute leukemia (MPAL) and disseminated B lymphoblastic lymphoma (B-LLy) when treated with high-risk ALL chemotherapy. The overall goal of this study is to understand if adding inotuzumab ozogamicin to standard of care chemotherapy maintains or improves outcomes in High Risk B-cell Acute Lymphoblastic Leukemia (HR B-ALL). The first part of the study includes the first two phases of therapy: Induction and Consolidation. This part will collect information on the leukemia, as well as the effects of the initial treatment, to classify patients into post-consolidation treatment groups. On the second part of this study, patients with HR B-ALL will receive the remainder of the chemotherapy cycles (interim maintenance I, delayed intensification, interim maintenance II, maintenance), with some patients randomized to receive inotuzumab. The patients that receive inotuzumab will not receive part of delayed intensification. Other aims of this study include investigating whether treating both males and females with the same duration of chemotherapy maintains outcomes for males who have previously been treated for an additional year compared to girls, as well as to evaluate the best ways to help patients adhere to oral chemotherapy regimens. Finally, this study will be the first to track the outcomes of subjects with disseminated B-cell Lymphoblastic Leukemia (B-LLy) or Mixed Phenotype Acute Leukemia (MPAL) when treated with B-ALL chemotherapy.

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PLEU21111 / APAL2020SC / Kazi

Lead Researcher: Rafi Kazi

This study aims to use clinical and biological characteristics of acute leukemias to screen for patient eligibility for available pediatric leukemia sub-trials. Testing bone marrow and blood from patients with leukemia that has come back after treatment or is difficult to treat may provide information about the patient's leukemia that is important when deciding how to best treat it, and may help doctors find better ways to diagnose and treat leukemia in children, adolescents, and young adults.

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PMLT12010 / ALTE05N1 / Kazi

Lead Researcher: Rafi Kazi

This clinical trial keeps track of and collects follow-up information from patients who are currently enrolled on or have participated in a Children's Oncology Group study. Developing a way to keep track of patients who have participated in Children's Oncology Group studies may allow doctors learn more about the long-term effects of cancer treatment and help them reduce problems related to treatment and improve patient quality of life.

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Povidone Iodine Study for Childhood Cavities

Lead Researcher: Dorota Kopycka-kedzierawski

This is a clinical trial to determine whether 10% Povidone Iodine prevents new cavities when applied to the teeth of children with Severe Early Childhood Caries (S-ECC). Study participants will be followed for approximately 24 months after receiving treatment. Children age 24 to 71 months with parents/guardians who are 18 or older are eligible. Children must be diagnosed with Severe-Early Childhood Caries (S-ECC) requiring treatment in the operating room.

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PRG Contact Database

Lead Researcher: Brian Keane

This future contact database will facilitate contact with prospective subjects, giving them greater opportunities to participate in behavioral and neuroimaging studies for which they may be eligible.

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Psychosis-Risk Outcomes Study (ProNET)

Lead Researcher: Steven Silverstein

The purpose of this research study is to collect information from individuals who are considered at clinically high risk for the possible development of psychosis. Information will also be collected from healthy individuals who are not considered at high risk for psychosis. This information will be used to guide future treatments. Participants will participate in interviews and cognitive tasks, provide blood samples, saliva and DNA, and get a scan of their brain. You may participate up to 2 years. You must be between 12 and 30 years old. There are other requirements to join the study. The study team can review them with you.

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RESET-SLE: Study to Evaluate the Safety and Efficacy of CABA-201 in People With Active Systemic Lupus Erythematosus

Lead Researcher: Christopher Palma

Systemic lupus erythematosus (SLE) is a disease where the immune system attacks healthy tissue. SLE can be unpredictable, flaring up and calming down over time. In some cases, it can damage organs like the kidneys, leading to a serious complication called lupus nephritis (LN). This can hurt your health and even be life-threatening. Unfortunately, there isn't a cure for lupus yet. Medications we have now can help manage the disease, but they often have side effects and sometimes aren't strong enough for severe cases. This is why scientists are actively researching new treatments for lupus, especially effective ones with fewer side effects, to help people with this challenging condition. This study will determine if a new drug, called CABA-201, will help SLE patient with lupus nephritis. You may be eligible to participate if you are 18-65 years old and have a clinical diagnosis of SLE.

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Safety, Tolerability, PK, and PD Study of PGN-EDODM1 in Participants With Myotonic Dystrophy Type 1

Lead Researcher: Johanna Hamel

The purpose of this study is to learn about the effects of an “investigational” drug, PGN-EDODM1, and to see how safe and tolerable PGN-EDODM1 is for people with myotonic dystrophy type 1 compared to placebo. The study consists of 2 periods: A Screening Period (up to 30 days) and a Treatment and Observation Period (16 weeks). You will come to the site for 6 visits over the course of the study. Compensation is provided for participating. You are eligible if you have a diagnosis of myotonic dystrophy type 1 and myotonia (muscles that do not relax after contraction).

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SGIP21027 / Semaphorin 4D / Mulkerin

Lead Researcher: Daniel Mulkerin

This trial will assess the safety and tolerability of Pepinemab in combination with Avelumab in patients with metastatic pancreatic adenocarcinoma that has progressed after first line chemotherapy. Phase 2 will assess the efficacy of this combination therapy.

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Social Engagement Coaching for Caregivers

Lead Researcher: Kathi Heffner

Taking care of someone who has dementia can become increasingly difficult. The well-being of the caregiver is important for both themselves and the person they care for. Healthy social connections are a vital part of this. The purpose of this study is to evaluate the effects of the Social Engage coaching program on caregivers’ well-being. This evidence-based, individualized program focuses on goals that are important to you and addresses the social barriers often encountered while caring for a loved one with dementia. The Social Engage program involves up to nine 30-minute virtual sessions (via Zoom or phone) conducted over 8-10 weeks, with flexible scheduling. Sessions are one-on-one, private meetings with a trained coach, and focused on your unique situation and the social connections that are important to you. Participation also involves 2 in-person study visits, one before and one after completing the Social Engage program. Visits are flexibly scheduled and parking is free. Study visits involve answering questions about yourself, including your mood and feelings of stress, and what caregiving has been like for you. We will also gather information about your physical and brain health.

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Specialized Phototherapy in Parkinson's Disease

Lead Researcher: Jamie Adams

This is a pivotal study to determine whether light therapy can improve non-motor and motor function in Parkinson's disease, on top of current best medical treatment. You may be eligible for this study if you have a diagnosis of Parkinson's disease.

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Spoken Language Comprehension in Adolescents​

Lead Researcher: Loisa Bennetto

​In this online study, an adolescent will schedule a Zoom appointment with a researcher and complete a computer-based listening study that may take up to 45 minutes. The parent will then complete background information surveys, which may take up to 20 minutes. Participants will be compensated via an electronic gift card. We hope that this research will lead to a better understanding of everyday spoken language communication and social interactions in adolescents with and without autism. We are currently recruiting adolescents aged 13-17 without autism. Please make sure to add an email address so that we can contact you!

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Study of T900607-Sodium in Chemotherapy Naive Patients With Hepatocellular Carcinoma.

The purpose of the study is to determine whether T900607-sodium is effective and safe in treating hepatocellular carcinoma, a type of liver cancer.

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Study on Oral Medication, Selgantolimod, for Treating Hepatitis B in Participants With Both HIV and Chronic Hepatitis B

Lead Researcher: Sonal Munsiff

This study will asses the safety of an oral medication, called Selgantolimod, which may help reduce the amount of hepatitis B virus in the blood. In this study, Selgantolimod will be given over a 6-month period to participants that are dually infected with HIV and chronic hepatitis B. Participants will need to have been taking suppressive antiviral therapy for both viruses - for at least the last 5 years - to be eligible.

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STUDY00006829: Cedars-Sinai - Microscopic Hematuria_UGUB21108

Lead Researcher: Edward Messing

To improve upon the non-invasive detection of BCa by further validating a multiplex ELISA assay directed at a BCa-associated diagnostic signature in voided urine samples of patients with microscopic hematuria.

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SWAT BE

Lead Researcher: Vivek Kaul

The purpose of this research study is to learn about the best approach to sample patients with known or suspected Barrett's esophagus (BE) by comparing the standard Seattle biopsy protocol to sampling using wide area transepithelial sampling (WATS3D). Barrett's esophagus is a common condition that is used to spot patients at increased risk of developing a type of cancer in the esophagus (swallowing tube) called esophageal adenocarcinoma. The 5-year survival rate is as low as 18% for patients who get esophageal adenocarcinoma, but the rate may be improved if the cancer is caught in its early stages. Barrett's esophagus can lead to dysplasia, or precancerous changes, which occurs when cells look abnormal but have not developed into cancer. If the abnormal cells increase from being slightly abnormal (low-grade dysplasia), to being very abnormal (high-grade dysplasia), the risk of developing cancer (esophageal adenocarcinoma) goes up. Therefore, catching dysplasia early is very important to prevent cancer. Endoscopic surveillance is a type of procedure where endoscopists run a tube with a light and a camera on the end of it down a patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells. Patients are being asked to be in this research study because they have been diagnosed with BE or suspected to have BE, and will need an esophagogastroduodenoscopy (EGD). Patients with BE undergo sampling using the Seattle biopsy protocol during which samples are obtained from the BE in a four quadrant fashion every 2 cm along with target biopsies from any abnormal areas within the BE. Another sampling approach is WATS3D which utilizes brushings from the BE. While both of these procedures are widely accepted approaches to sampling patients with BE during endoscopy, there is not enough research to show if one is better than the other. Participants in this study will undergo sampling of the BE using both approaches (Seattle biopsy protocol and WATS-3D); the order of the techniques will be randomized. Up to 2700 participants will take part in this research. This is a multicenter study involving several academic, community and private hospitals around the country.

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The REBALANCE Study - a Study of the May Health System in women with infertility

Lead Researcher: Wendy Vitek

The purpose of this research is to investigate the safety and effectiveness of an investigational medical device for the treatment of infertility in women with polycystic ovary syndrome (PCOS). You may be eligible for this study if you are 18 - 40 years old and are infertile with evidence of PCOS. Other criteria may apply.

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The REPLACE Registry-for people who take Cholbam/Kolbam (Cholic Acid)

Lead Researcher: Nanda Kerkar

This is a study for people who take Cholbam/Kolbam also known as Cholic acid. You will be in this study for 10 years and we will collect information about your health.

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To Find the Best Dose of pVGI.1(VEGF2) to Benefit Angina Patients When Given With an Experimental Injection Catheter

The purpose of this study is to determine the optimum effective dose of recombinant plasmid DNA [pVGI.1(VEGF2)] gene therapy administered using an experimental cardiac direct injection catheter (Stiletto™) system needed to benefit patients with severe Angina Pectoris.

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Total-Body Irradiation, Fludarabine, and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer

RATIONALE: Radiation therapy uses high-energy x-rays to damage cancer cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with donor peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining total-body irradiation with fludarabine and donor peripheral stem cell transplantation in treating patients who have hematologic cancer.

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UBMT15029 / Cord Blood IIT / Omar Aljitawi

Lead Researcher: Omar Aljitawi

This study is a single-center, treatment protocol with 4 possible preparative regimens, designed to validate the process of umbilical cord blood stem cell transplantation at our institution.

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UBMT17044 / HBO-UBC / Omar Aljitawi

Lead Researcher: Omar Aljitawi

The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).

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UBRS20139 / FACT-5 / Ajay Dhakal

Lead Researcher: Ajay Dhakal

The purpose of this research is to look at the safety and effectiveness of a HER2-targeted therapy neratinib when given with capecitabine, a chemotherapy, for breast cancer patients with brain metastases whose tumors were HER2-negative by standard tests but showed abnormal HER2 activity based on the CELsignia results.

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UBRS20152 / BTCRC BRE15-024 / O'Regan

Lead Researcher: Ruth O'Regan

This is an open label, multi-institutional, single arm phase II trial of ribociclib in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization or blinding is involved.

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UBRS21032 / HCRN-BRE17-141 / O'Regan

Lead Researcher: Ruth O'Regan

Patient will be treated with neratinib, an aromatase inhibitor and trastuzumab for 24 weeks prior to surgery, following an initial 3 weeks of neratinib alone, aromatase inhibitor alone or the combination of neratinib and an aromatase inhibitor. A breast biopsy will be performed prior to Day 1 of week 4 of treatment. Following surgery, patients will receive standard of care HER2-directed and endocrine therapy at the treating physician's discretion.

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UBRT21040 / Early START / Nimish Mohile (formerly Sara Hardy)

Lead Researcher: Nimish Mohile

High grade gliomas (HGGs) are rapidly progressive brain tumors resulting in death for most patients between 6 months and 2 years after diagnosis. It is important for patients with HGG to discuss and document their wishes at the end of life. However, many of these patients experience early changes in cognition which impede their decision-making. For this reason, these patients should have early discussions with their providers. However, implementation of this remains challenging in clinical practice. In this study, we will create an Early STructured Advanced care Referrals by Telehealth (Early START) visit for patients soon after their initial oncology visit. A checklist and pre-visit guide were developed to help guide the visit for both the provider and patient. Providers will receive special training in running these visits. Caregivers and/or family members will be encouraged to participate. Visits will be done using video or telephone and recorded. For patients who do not have access to technology for these visits, it will be provided. After the visit, patients, caregivers and/or family who participated, and providers will fill out surveys to address feasibility of having these extra visits and improve the visits for future. Patients will be followed until death. Caregivers and/or family who participated will be asked about whether end of life was in line with the patient's wishes. We will also use the patient's medical record to assess other aspects of end of life. We will compare end of life outcomes with other similar patients treated at our center.

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UCCS19102 / MAAT-G JIT (Breast) / Magnuson

Lead Researcher: Allison Magnuson

Cancer-related cognitive dysfunction (CRCD) affects up to 75% of patients receiving chemotherapy and older adults are at greater risk of developing CRCD, which can negatively affect their functional independence and quality of life. Memory and Attention Adaptation Training (MAAT) is a promising treatment for CRCD that improves perceived cognition in younger cancer survivors, but needs to be adapted for older adults to address their unique needs. The proposed study will adapt MAAT for older adults using feedback from key stakeholders (older adults with cancer and their caregivers), and subsequently test the ability of MAAT to improve or maintain cognition for older adults with breast cancer receiving adjuvant chemotherapy.

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UCCS21043 / Go-EXCAP II / Loh

Lead Researcher: Kah Poh Loh

This is a phase 2 randomized controlled trial (RCT) to assess the preliminary efficacy of the a mobile health exercise intervention (GO-EXCAP) versus a chemotherapy education control in 100 older patients with MN receiving outpatient chemotherapy on physical function and patient-reported outcomes (fatigue, mood, and quality of life). We will also explore the effect of the intervention on TNFα and related cytokine gene promoter methylation and their gene and protein expression.

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UGIP20027, Dunne, CA209-7WU, Pancreatic Ductal Adenocarcinoma, SX-682, Nivolumab

Lead Researcher: Richard Dunne

The main purpose of this research study is to determine the maximum tolerable dose (MTD) of SX-682 in combination with nivolumab in patients with metastatic pancreatic ductal adenocarcinoma who have completed at least 16 weeks of first line chemotherapy treatment without evidence of disease progression.

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UGUK17036 / Fung RCC Carevive Pilot IIT / Chunkit Fung

Lead Researcher: Chunkit Fung

To determine if Carevive software, which monitors treatment-related toxicities and then generates self-care management plans for these symptoms, will be feasible to implement among patients with metastatic renal cell carcinoma (RCC). Additionally for collection of preliminary data on treatment-related toxicities, quality of life, distress level, and drug adherence.

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UGUP18071 / DORA / Chunkit Fung

Lead Researcher: Chunkit Fung

The purpose of this study is to compare any good and bad effects of using radium-223 along with docetaxel chemotherapy treatment versus using docetaxel alone. Earlier studies helped show that the combination is safe, but the combination has not been proven to work better than either drug alone. The goal of this study is to find out if combining docetaxel and radium-223 is better than giving either drug by itself.

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UGYO17017 / MD Anderson / Richard Moore

Lead Researcher: Richard Moore

The goal of this clinical research study is to evaluate a method involving 4 blood tests called CA-125, HE4, HE4 antigen autoantibody complexes, and osteopontin that may be helpful in the early detection of ovarian cancer in women who are at low risk.

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ULAB03012 / LEO / Richard Burack

Lead Researcher: Walter Burack

The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.

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ULAB21028 / LEO / Friedberg

Lead Researcher: Jonathan Friedberg

The goal of this infrastructure protocol is to build and maintain a large and diverse observational cohort study to support broad and cutting-edge research focused on NHL prognosis and survivorship. The LEO cohort will promote identification of clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors that impact multiple outcomes (including event-free, overall and lymphoma-specific survival; new onset comorbidities; and patient-reported outcomes). This resource also will allow examination of the interaction among these factors in order to better understand the clinical and molecular epidemiology of outcomes in NHL. Ultimately, this approach will drive discovery and validation of treatment endpoints, improve prognostication, and identify novel approaches to improve short and long-term outcomes for NHL patients.

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ULEU07047 / RSRB20123 / Michael Becker

Lead Researcher: Jane Liesveld

This study is being performed to develop assays to determine the impact of the therapy patients receive for treatment of AML or MDS and to determine if these tests can identify those patients who are at a greater risk for having their disease relapse.

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ULYM18040 / DLBCL / Carla Casulo

Lead Researcher: Carla Casulo

The overarching goals of this study are to measure levels of circulating tumor DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL), to assess the change in ctDNA during treatment in order to prospectively identify markers of treatment failure, and to use ctDNA as a future tool for response adapted therapy.

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ULYM20030 / ML41690 Polatuzumab / Patrick Reagan

Lead Researcher: Patrick Reagan

The purpose of this study is to test the effectiveness and safety of polatuzumab vedotin in combination with R-miniCHP in patients 75 years and older with DLBCL.

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UMLT19186 / K08 JIT / Ramsdale

Lead Researcher: Erika Ramsdale

This is a single-site cluster-randomized trial to assess efficacy and implementation outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP) and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll 6 patients each and will be randomized to either a pharmacist-led deprescribing intervention or patient education intervention. Initial focus groups with oncologists, nurses, pharmacists, primary care physicians, and patients will provide data for initial adaptations to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial cohort to further refine and adapt the pharmacist-led intervention.

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UMLT20123 / Van Veldhuizen / SMM & Prostate

Lead Researcher: Brea Lipe

To explore the use of curcumin and piperine supplementation at a dose of 4 gram/5mg twice a day in early stage prostate cancer patient undergoing active surveillance or patients on observation for MGUS/ low-risk smoldering myeloma.

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UMLYM23012 // 22-702 // Casulo

Lead Researcher: Danielle Wallace

The purpose of this study is to determine how effective and safe the combination of rituximab and epcoritamab is in treating patients with Follicular Lymphoma (FL) and who have not received other treatments for their lymphoma. The names of the study drugs involved in this study are: * Rituximab (a type of monoclonal antibody therapy) * Epcoritamab (a T-cell bispecific antibody)

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UOCPC22008 / Triadic / Magnuson

Lead Researcher: Allison Magnuson

To gather key stakeholder input for feedback on the adaption of the COACH GA intervention (i.e., develop COACH-Cog) to enhance triadic communication among oncologists, care partners and patients with ADRD.

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UOCPC22010 / UR-GOAL 2 / Kah Poh Loh

Lead Researcher: Kah Poh Loh

The objective of this study is to conduct a pilot randomized trial to evaluate the preliminary efficacy of the UR-GOAL tool vs. usual care in improving shared decision making and communication between 100 older patients with AML and their oncologists.

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UOCPC22022 / E-Co Study / Kah Poh Loh

Lead Researcher: Kah Poh Loh

The objective of the study is to evaluate the feasibility of a combined mobile health exercise and cognitive rehabilitation intervention and its effect on cognition in a single-arm pilot study that recruits cancer survivors.

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UOCPC22065 / SONATA / Kah Poh Loh

Lead Researcher: Kah Poh Loh

The purpose of this study is to see if a social network support program (SOcial Networks to Activate Trust \& Adherence or SONATA) is helpful for older individuals receiving cancer treatment. The SONATA program will last for about 4 months. There are a total of 6 coaching sessions. The first 5 sessions will be held approximately every 1 to 2 weeks. Session 6 or the final session will be held approximately 1 to 2 months after session 5. Each session will last for about 1 to 2 hours.

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UOCPC23054 / GAM-CRT / Mohile

Lead Researcher: Supriya Mohile

This clinical trial tests how well a geriatric assessment (GA) with GA-directed treatment recommendations, compared to GA with usual care, works in identifying risk factors, reducing chemotherapy radiation toxicity and functional decline, and improving the overall quality of life in older patients with non-small cell lung cancer (NSCLC). Older patients with lung cancer undergoing chemotherapy are at an increased risk of adverse outcomes including treatment toxicity and functional and physical consequences. This makes it very challenging for the physicians to balance the benefits against the risk of chemotherapy in older cancer patients. A geriatric assessment may be useful in identifying risk factors for chemotherapy radiation toxicity. Communicating these geriatric assessment findings and assessment-based recommendations to a patient's treating physicians may help them make more informed decisions about treatment options for patients. Making treatment decisions using GA-based recommendations may reduce adverse events and improve outcomes in patients receiving treatment for NSCLC.

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UOCPC23082 / SCOPE / Loh

Lead Researcher: Kah Poh Loh

This research study is evaluating whether primary palliative care is an alternative strategy to specialty palliative care for improving quality of life, symptoms, mood, coping, and end of life outcomes in patients with acute myeloid leukemia (AML).

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URO105883/ADVANCED-1-Ph1b/2/Tabayoyong/RSRB8538

Lead Researcher: William Tabayoyong

This study is open-label dose expansion study to investigate the safety and toxicity of intravesical treatment of high-grade NMIBC (HGTa or CIS, including CIS with concomitant Ta) after transurethral resection of bladder tumor (TURBT) and/or biopsy using TARA-002 in adults unable to obtain intravesical Bacillus Calmette-Guérin (BCG), adults who have received at least one dose of intravesical BCG or adults who have received at least one dose of intravesical chemotherapy. After completion of the dose escalation phase (Phase 1a) and after the RP2D has been established, the dose expansion phase (Phase 1b) will start enrollment of subjects with CIS NMIBC with active disease to further evaluate the safety and preliminary efficacy of TARA-002, at the established RP2D. CIS NMIBC with active disease is defined as disease present at the last cystoscopic evaluation prior to signing the ICF. Subjects enrolled in the dose expansion phase will not include subjects previously enrolled and treated in the dose escalation phase. All subjects will receive 6 weeks of treatment at the established RP2D.

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Vaping/ Peter A. Wyman

Lead Researcher: Peter Wyman

Rates of adolescent vaping are increasing rapidly. Current high school student use of electronic vaping products (EVPs) rose from 1.5% in 2011 to 20.8% in 2018 - an increase from 220,000 to 3.05 million adolescent users. Effective, school-based interventions are urgently needed to protect adolescents from initiating or continuing use of electronic vaping products (EVPs). This study leverages a state-supported prevention initiative to test the effectiveness of a promising intervention that trains 8th-9th grade student peer leaders to deliver school-wide vaping prevention campaigns with ongoing adult mentoring. If study hypotheses are supported, the study will provide the first evidence of a school-based preventive intervention that reduces adolescent vaping behaviors, as well as insight into how peer communications can be harnessed to prevent vaping.

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VAPOR 2 Study Pivotal Study Clinical Protocol/Frye/IUGUP23019

Lead Researcher: Thomas Frye

The purpose of this study is to evaluate the safety and efficacy of the Vanquish Water Vapor Ablation Device ("Vanquish") in treating subjects with Gleason Grade Group 2 (GGG2) localized intermediate-risk prostate cancer.

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Vision Loss Impact due to Stroke on Steering when Driving

Lead Researcher: Krystel Huxlin

Stroke is the main cause of damage to the part of the brain that processes visual information from the eyes. This can lead to vision loss even when there is no damage to the eyes. The purpose of this research is to better understand how people compensate for this type of vision loss by studying the steering behavior of people when driving. Using a novel Virtual Reality (VR) program, we will gather data from people while they drive in a simulated environment on the computer. If you are a resident of the US or Canada, have a driver's license or have had a driver's license in the past, and had a stroke that affected your vision when you were 21-80 years of age, you may be eligible to participant.

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