Cancer Screening Research Network - North Carolina Hub (CSRN-NC HUB)

Although evidence-based 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 early 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 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 seeks to create the Cancer Screening Research Network (CSRN). At the University of North Carolina Lineberger Comprehensive Cancer Center, we have formed a multi-disciplinary team that is highly qualified and eager to join the NCI CSRN as the CSRN North Carolina Hub (CSRN NC Hub). Our extensive research experience in cancer screening trials and NCI clinical trials infrastructure, and our screening research affiliations both with UNC Health, our statewide health system, and with Federally Qualified Health Centers (FQHCs), demonstrates our capacity to enroll a large, comprehensive and representative populations. Our overarching aim is to accelerate research on emerging cancer screening technologies in partnership with the CSRN. In this application, we propose to (1) establish CSRN NC Hub infrastructure and linkages to build capacity for future, larger studies of MCDs and other novel cancer screening tests; and (2) enroll a comprehensive and representative participant population and conduct the Vanguard feasibility trial. We will build a population-based recruitment hub in North Carolina representative of the state’s population. For the Vanguard trial, we will enroll 2000 participants from two selected UNC Health sites and one FQHC, using a mix of innovative recruitment and retention methods demonstrated to be effective in our prior studies. Based on experience, we believe the CSRN NC Hub is exceptionally well-positioned to support the critical CSRN goal of recruiting a screening-eligible population representative of both NC and the US. As part of the CSRN, the NC ACCESS Hub will significantly contribute to the rapid evaluation of emerging cancer screening technologies and future studies of MCDs and other novel screening technologies that will yield high quality evidence to inform the use of these tests in clinical practice across US populations.