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

PROJECT SUMMARY/ABSTRACT
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 historically underrepresented communities including specifically
Black, Hispanic, and American Indian 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; (2) enroll a diverse patient population and conduct the Vanguard feasibility trial; and (3)
conduct preliminary qualitative research to elicit perspectives of diverse communities regarding MCD
screening. We will build a population-based, racially diverse recruitment hub in North Carolina that leverages
the geographic and demographic diversity of the state. 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 past experience, we believe the CSRN
NC Hub is exceptionally well-positioned to 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 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 diverse US populations.