Screening With a DNA Blood Test to Address Colorectal Cancer Inequities

Colorectal cancer (CRC) screening participation is suboptimal and associated with inequities in CRC outcomes by race/ethnicity and socioeconomic position. A novel, cell free DNA (cfDNA) blood test has potential to increase participation, but has not been studied in groups at highest risk for adverse CRC outcomes. Among patients age-eligible for colorectal cancer screening, not up-to-date, we propose a 2-arm, pragmatic, randomized controlled trial comparing offers of standard screening options (at home fecal immunochemical test (FIT) or colonoscopy) vs. offers of expanded options (at home FIT, colonoscopy, or in clinic cfDNA plus at home FIT), set at a large Federally Qualified Health Center serving individuals at increased risk for inequities in CRC outcomes. Results will inform guideline and policy makers on whether cfDNA should be supported as a screening option, and support planning for a large-scale trial examining impact of a cfDNA option for screening on CRC and advanced neoplasia detection.

NCT Number	NCT06929481
Lead Sponsor	University of California, San Diego Collaborators: CUREBOUND, INC., Family Health Centers of San Diego
Conditions	Colorectal Cancer Screening, Colorectal Cancer (CRC)
Enrollment	340 participants
Start Date	2025-04-28
Primary Completion	2026-07 (estimated)
Study Completion	2026-07 (estimated)
Updated on ClinicalTrials.gov	2026-06-26