Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) trial Biorepository

National Cancer Institute, Frederick MD

Investigators

Abstract

The CONFIRM biorepository collects blood prior to screening in both the colonoscopy and FIT arms, allowing for baseline analyses and the subsequent tracking of advanced neoplasia and cancer outcomes. The CONFIRM biorepository would include consent for research on colonic tissues that are not needed for clinical purposes (i.e. residual tissue from tissue blocks). Tissue from initial and all follow-up colonoscopies in the colonoscopy arm and tissues from any colonoscopies in the FIT arm would be available for research, which may allow us to develop a predictive model for the development of advanced neoplasia over time. The goal of this IAA is to create a biorepository of blood and tissue from veterans enrolling in the Department of Veterans Affairs (VA)?s Cooperative Studies Program (CSP) study, Colonoscopy vs. Fecal Immunochemical Test in Reducing Mortality from Colorectal Cancer (CONFIRM) trial. This biorepository would be a valuable resource for genetic and genomic studies. Augmenting the rich clinical data being collected would allow us to use blood and tissue specimens from the biorepository for defining risk for colorectal neoplasia (including cancer and adenoma endpoints). Specifically, these tissues including colorectal biopsies and blood samples would be stored at VA central biospecimen facility and could be used for developing algorithms for personalizing and targeting the approach to colorectal cancer screening and surveillance based on clinical, diagnostic (i.e. results of fecal immunochemical tests, or FIT), and genomic risk profiles. This approach would inform risk stratification for colorectal cancer screening and surveillance, allowing us to target efforts to those most likely to benefit. In summary, the aims of this collaboration is to collect and store biospecimens for future studies with the overarching goal of personalized screening and surveillance strategies based on risk, reducing over screening or surveillance in lower risk groups, with subsequent potential reductions in cost and adverse events.