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Ensuring Successful Biomarker Studies in Bladder Preservation Clinical Trials for Non-muscle Invasive Bladder Cancer


Journal Article

McConkey, David J.; Baumann, Brian C.; Cooper Greenberg, Stephanie; DeGraff, David J.; Delacroix, Scott E.; Efstathiou, Jason A.; Foster, Jared; Groshen, Susan; Kadel, Edward E.; Khani, Francesca; Kim, William Y.; Lerner, Seth P.; Levin, Trevor; Liao, Joseph C.; Milowsky, Matthew I.; Meeks, Joshua J.; Miyamoto, David T.; Mouw, Kent W.; Pietzak, Eugene J.; Solit, David B.; Sundi, Debasish; Tawab-Amiri, Abdul; West, Pamela J.; Wobker, Sara E.; Wyatt, Alexander W.; Apolo, Andrea B.; Black, Peter C.



Bladder Cancer



Tissue banking FFPE RNA urine tumor DNA plasma tumor DNA

Recent technological advances have created new opportunities for performing biomarker studies within the National Cancer Institute’s (NCI’s) National Clinical Trials Network (NCTN) clinical trials. These new platforms yield more robust measurements when tissue and blood handling is optimized. At the same time, there is a strong interest in banking tissue and derivatives, such as DNA and RNA, for future biomarker studies using novel platforms that may emerge during the intervening time to trial completion. The NCI recently hosted a Clinical Trials Planning Meeting focused on two trial concepts for bladder preservation in patients with high-risk non-muscle invasive bladder cancer (NMIBC) and the correlative translational research to be integrated into these trials, where experts discussed prioritization for the use of patient samples, and a framework for best practices emerged. The overall goal of this meeting report is to summarize this discussion and to provide the working group’s recommendations for biospecimen handling for future bladder preservation studies.

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