Transdisciplinary Team Science in Colorectal Cancer Prognosis: the ColoCare Study

PROJECT SUMMARY. Colorectal cancer (CRC) is the second most common cancer among men and women in the U.S., leading to over 50,000 deaths per year. Research aimed at reducing CRC’s high burden, discovering/validating novel biomarkers associated with prognosis, addressing the growing epidemic of early-onset CRC, and countering poorer CRC outcomes is of pressing importance. CRC patient cohorts that include all patients and longitudinally ascertain clinical data and biospecimens are essential for pursuing these critical objectives. The ColoCare Study is a large, multi-institutional prospective survivorship cohort that enrolls newly diagnosed patients with CRC from all geographic and other backgrounds. CRC survivorship cohorts are rare and ColoCare is unique given its collection of detailed epidemiologic and clinical data and a variety of biospecimens at multiple time points. This design enables innovative survivorship research that spans lifestyle/behavioral factors and translational studies aimed at discovering and validating novel molecular, blood- and microbiome-based biomarkers related to the risk of adverse CRC outcomes. Such research can inform treatment decision-making, interventions aimed at improving key clinical and patient reported outcomes, and the development of novel therapeutics. The ColoCare Study has enrolled >3,000 patients with a median of 2.1 years of follow-up and biospecimen collections including tumor tissue and serial blood, stool, and urine samples. Despite being a young cohort, ColoCare has already supported 70 published papers and 79 projects that include 72 external investigators. Continued U01 infrastructure support is critical to sustain and grow this valuable resource for CRC survivorship research. Here, we will pursue the following aims: (1) Increase the size of the cohort from 3,361 to 4,157 participants, including enhanced recruitment of populations that experience poorer CRC outcomes and patients receiving novel therapies. (2) Extend participant follow-up to 5-years through both active follow-up (biospecimens; questionnaires; medical record abstractions) and passive follow-up (SEER/state cancer registries and National Death Index). (3) Maintain and expand the ColoCare biorepository, including collection of tumor tissue samples and longitudinal collections of blood and stool samples. (4) Maintain and expand the ColoCare Central Data Warehouse, the capabilities of our study portal to encourage and facilitate requests from external and internal investigators, and engagement with our Community Advisory Board to advance patient participation and the public dissemination of knowledge generated by ColoCare. With continued infrastructure support, this unique and comprehensive resource will continue to enable a wide range of impactful colorectal cancer survivorship research.