Screening With a DNA Blood Test to Address Colorectal Cancer Inequities

NAEnrolling by invitationINTERVENTIONAL
Enrollment

340

Participants

Timeline

Start Date

April 28, 2025

Primary Completion Date

December 31, 2025

Study Completion Date

May 31, 2026

Conditions
Colorectal Cancer ScreeningColorectal Cancer (CRC)
Interventions
DEVICE

Cell free DNA (cfDNA) blood test

"The intervention is a novel blood test that evaluates circulating cell free tumor DNA (cfDNA) and detects colorectal cancer (CRC). Recently, the cfDNA test has been shown to have 83% sensitivity and 90% specificity for CRC detection, and 13% sensitivity for advanced polyp detection, heralding a new screening strategy postulated to be highly convenient and acceptable. The cfDNA test is made by Guardant Health, FDA approved for average risk colorectal cancer screening, and marketed with the brand name Shield. Patients opting for the cfDNA test will also be requested to complete an at home FIT."

OTHER

At home Fecal Immunochemical Test (FIT) or Colonoscopy

The usual care group will be offered standard colorectal cancer screening options to choose from: at home FIT or colonoscopy.

Trial Locations (1)

92113

Family Health Centers of San Diego, Logan Heights site, San Diego

All Listed Sponsors
collaborator

CUREBOUND, INC.

UNKNOWN

collaborator

Family Health Centers of San Diego

OTHER

lead

University of California, San Diego

OTHER