Screening With a DNA Blood Test to Address Colorectal Cancer Inequities

Summary

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.

Conditions

• Colorectal Cancer Screening
• Colorectal 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.

Sponsors & Collaborators

• CUREBOUND, INC.

  collaborator UNKNOWN

• Family Health Centers of San Diego

  collaborator OTHER

• University of California, San Diego

  lead OTHER

Principal Investigators

• Samir Gupta, MD, MSCS, AGAF · University of California, San Diego

• Job G Godino, PhD · Family Health Centers of San Diego

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

45 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-04-28

Primary Completion

2025-12-31

Completion

2026-05-31

FDA Device

Yes

Countries

• United States

Study Locations