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Genomic analysis and biorepository research study takes aim at metastatic bladder cancer

Hoosier Cancer Research Network is partnering with the Bladder Cancer Advocacy Network (BCAN) to conduct a large-scale bladder cancer genomic analysis and biorepository research study.

Known as UC-GENOME (HCRN GU15-217), the research study is the first project of the Bladder Cancer Genomics Consortium (BCGC), a collaborative effort between BCAN and major medical centers. The BCGC’s goal is to develop an enriched understanding of the genomic profile of bladder cancer to facilitate the development of novel therapeutics.

The research study is open to accrual at the University of North Carolina Lineberger Comprehensive Cancer Center in Chapel Hill, N.C. Additional sites are expected to open soon.

Bladder cancer is the fifth most commonly diagnosed cancer in the United States, with nearly 75,000 new cases and 16,000 deaths in 2015. The current standard approach for patients with metastatic disease is chemotherapy, and only recently has there been an FDA-approved therapy for patients with metastatic disease who progress on first-line therapy.

“Although chemotherapy is associated with a survival benefit, it does not cure patients, and therefore patients need subsequent therapies,” said Matthew Milowsky, MD, of the UNC Lineberger Comprehensive Cancer Center. Milowsky is the research study’s sponsor-investigator and the chair of the BCGC Genomics Advisory Board.

While limited options exist for patients with metastatic disease, Milowsky notes that recent collaborations have led to the discovery of new targets for potential treatment.

“We learned from the Cancer Genome Atlas experience in 2014 that bladder cancer has many potential actionable alterations,” Milowsky said. “These are genetic events that are potentially targetable with drugs that are either already on the shelf or in clinical trials.”

UC-GENOME builds on these discoveries by incorporating next generation sequencing (NGS) to identify genomic data about a patient’s tumor. NGS will help researchers determine whether targetable events have occurred in the patient’s tumor that could guide treatment options.

A co-equal aim of UC-GENOME is to establish a biospecimen repository to aid future research. “The goal of this is to perform, down the line, collaborative translational research to drive the field forward,” Milowsky said.

Funding for UC-GENOME is provided by the Bladder Cancer Advocacy Network, a not-for-profit organization established in 2005 as the first national patient-based advocacy organization for bladder cancer.

UC-GENOME will enroll about 200 subjects with metastatic urothelial carcinoma of the bladder, urethra, ureter, or renal pelvis. Additional eligibility requirements must be met to enroll.

For more information about this research study, including full eligibility requirements, visit www.clinicaltrials.gov (study #NCT02643043).

About Hoosier Cancer Research Network:

Hoosier Cancer Research Network (formerly known as Hoosier Oncology Group) conducts innovative cancer research in collaboration with academic and community physicians and scientists across the United States. The organization provides comprehensive clinical trial management and support, from conception through publication. Created in 1984 as a program of the Walther Cancer Institute, Hoosier Cancer Research Network became an independent nonprofit clinical research organization in 2007. Since its founding, Hoosier Cancer Research Network has initiated more than 160 trials in a variety of cancer types and supportive care, resulting in more than 350 publications. More than 5,000 subjects have participated in Hoosier Cancer Research Network clinical trials.