A clinical trial is a study conducted with actual patients, usually to evaluate a new treatment. Each study is designed to answer scientific questions and to find new and better ways to help patients.
Technical Title: Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC): Data and Biospecimen Repository
Disease Type: Patients with a diagnosis of HLRCC as a result of 1) a genetic alteration in the fumarate hydratase (FH) gene or 2) have clinical features and a family history of an alteration in the FH gene.
Basic information: Hereditary leiomyomatosis and renal cell cancer (HLRCC) is a disorder in which affected individuals tend to develop benign tumors containing smooth muscle tissue (leiomyomas) in the skin and, in females, the uterus. This condition also increases the risk of kidney cancer. The purpose of this study is to construct a biologic specimen bank for research purposes. Determining which additional factors contribute to the development of HLRCC manifestations, detecting biomarkers that may lead to earlier diagnosis, and learning more about the clinical outcomes with treatment strategies is the ultimate goal of the research. This biologic specimen bank will study the genetic and biological factors contributing to the development of Hereditary Leiomyomatosis and Renal Cell Cancer (HLRCC).
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Technical Title: Stool Microbiome and Immunotherapy Response and Toxicity
Disease Type: Patients with recently diagnosed metastatic kidney cancer (mRCC) or metastatic urothelial carcinoma (mUC) and new prescription for immunotherapy.
Basic information: Cancer immunotherapy is now used in many cancers including drugs which block a specific pathway (PD-1). Exciting data has linked the response to immune therapy with the type of stool bacteria that live in the gut. We now have the potential to study the bacteria which live in one’s gut by testing the stool. We still do not know which stool bacteria are associated with better response, but if this is discovered in the future, there is the potential to alter the bacteria in order to improve outcome with these cancer therapies. We are performing this study in order to better understand which bacteria are present in our patients and if it changes with therapy. We hope to obtain more information on which bacteria (if any) are associated with an improved outcome and less toxicity to inform future work in this area.
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Technical Title: The Enhanced Renal Mass Biopsy: Impact on Clinical Decision-Making for the Localized Renal Mass
Disease Type: Individuals who have a renal mass and a prior renal biopsy but have not yet decided on management.
Basic information: Renal masses may be cancer or benign tumors. Renal biopsies can sample the tissue prior to treatment. There are limitations of what a biopsy can provide and often patients proceed with surgery due to uncertainty about the aggressiveness of the tumor. Genetic analyses are possible on the tissue removed from a biopsy and can provide further information on a tumor’s future behavior. We are interested in understanding how this genetic information can help a patient decide on which treatment may be best for them.
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Technical Title: A Phase 3 Randomized, Double-Blind Study of Nivolumab Monotherapy or Nivolumab Combined with Ipilimumab Combination vs Placebo in Participants with Localized Renal Cell Carcinoma Who Underwent Radical or Partial Nephrectomy and Who Are at High Risk of Relapse
Disease Type: Patients with renal cell carcinoma (a type of kidney cancer) who are planned to have a nephrectomy (surgical removal of the kidney)
Basic information: The purpose of this study is to compare the effectiveness, safety, and tolerability of an investigational drug combination in patients with localized kidney cancer that have had their tumors completely removed, but are at risk of having their cancer return. The drug combination includes two drugs: nivolumab (also known as OPDIVO) and ipilimumab (also known as Yervoy).
For More Detailed Information, Contact:
• Brian Shuch, MD, Principal Investigator
• Sara Rodriguez, Study Coordinator, (310) 794-2877
Read more about this study (NCT03138512) on ClinicalTrials.gov.
Technical Title: 99mTc-sestamibi Imaging for the Characterization of Renal Masses:
Impact on Clinical Decision Making
Disease Type: Patients with recently diagnosed renal masses
Basic information: The purpose of this study is to examine how doctors and patients use information from 99mTc-sestamibi SPECT/CT, a type of nuclear medicine scan, to decide how to manage newly diagnosed renal masses (kidney tumors). Patients on this study will undergo 99mTc-sestamibi SPECT/CT scans as part of their routine care.
For More Detailed Information, Contact:
• Brian Shuch, MD, Principal Investigator
• Sara Rodriguez, Study Coordinator, (310) 794-2877
Technical Title: PROSPER RCC: EA8143: A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy
Disease Type: Patients with renal cell carcinoma (a type of kidney cancer) who are planned to have a nephrectomy (surgical removal of the kidney)
Basic information: The purpose of this study is to compare the effects of a drug called nivolumab (also known as OPDIVO®), before and after the kidney cancer surgery to using the usual approach of surgically removing the kidney cancer followed by standard post-operative follow-up and monitoring. Nivolumab is a drug that may help stimulate your immune system to attack any cancer cells that may remain after surgery. The addition of nivolumab to the usual surgery could prevent your cancer from returning but it could also cause side effects.
For More Detailed Information, Contact:
• Brian Shuch, MD, Principal Investigator
• Rosleen Mala, Study Coordinator, (310) 794-3879
For information on inclusion and exclusion criteria please call our Clinical Trials Office - 310-206-5930
