Administrative Supplement: CSRN Vanguard Study

This application is being submitted in response to the NOSI identified as NOT-CA-24-111. Although evidencebased cancer screening protocols exist for several common cancer types, an estimated 70% of cancer deaths are due to cancers for which no early detection test is yet available. Multi-cancer detection tests (MCDs) seek to fill this gap using advances in cell-free DNA detection to identify multiple cancer types from a single blood draw. This new approach to cancer screening has the potential to revolutionize early detection and reduce cancer mortality. MCDs are rapidly moving toward general commercial availability, and studies in diverse populations are urgently needed to improve our understanding of the risks and benefits associated with these tests and how best to implement them appropriately and effectively. To address these gaps the National Cancer Institute created the Cancer Screening Research Network (CSRN) to evaluate novel screening technologies with the first objective being to understand the feasibility of a randomized control trial for MCDs. To do so, the CSRN will implement the Vanguard feasibility study. The University of North Carolina Lineberger Comprehensive Cancer Center is one of 9 CSRN ACCESS (Accrual, Enrollment, and Screening Sites) Hubs. To increase the likelihood of successfully enrolling 2000 patients from the NC ACESS Hub onto the Vanguard Study, including recruiting diverse and historically underrepresented populations from UNC Health, our statewide health system, and participating Federally Qualified Health Centers (FQHCs), additional funds are needed beyond what was requested in the parent grant. Our overarching aim is to accelerate research on emerging cancer screening technologies in partnership with the CSRN. In this administrative supplement application, we propose to (1) support enrollment goals and recruitment of a diverse patient population by hiring additional clinical research staff dedicated to Vanguard Study recruitment and enrollment ; (2) hiring and deploying a clinical trials patient navigator who will provide clinical trial education and enrollment support at institutional and community partner site location distal to the main campus NC Hub. This navigator will connect patients underrepresented in clinical trials with providers and clinical trial opportunities, as well as act as a navigator for enrolled Vanguard Study patients who receive a positive MCD test to ensure timely workup and diagnostic resolution; (3) cover the cost of the initial diagnostic work-up and any associated travel costs for patients who receive a positive MCD test; and (4) implement biospecimen workflow support with the central UNC laboratory to insure specimen integrity. These additions to our NC ACCESS Hub team, and the ancillary resources provided to participants will support the critical CSRN goal of recruiting a diverse screening eligible population representative of the racial, ethnic, and rural/urban distribution of both NC and the US. As part of the CSRN, the NC ACCESS Hub is excited to significantly contribute to the rapid evaluation of emerging cancer screening technologies and future studies of MCDs, but recognizes the challenges associated with recruitment, retention and support of diverse populations, thus requests supplemental funding for high yield interventions that will serve to promote collection of high-quality evidence to inform the use of these tests in clinical practice across diverse US populations.