Screening With a DNA Blood Test to Address Colorectal Cancer Inequities

Running, not enrolling · Not applicable

Conditions studied: Colorectal Cancer Screening, Colorectal Cancer (CRC)

In brief

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.

Key facts

Study ID

NCT06929481

Run by

University of California, San Diego

People needed

340

Starts

2025-04-28

Expected to finish

2026-07-01

Last updated by the study team

2026-06-26

Who can join

Age: 45 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Persons, aged 45 to 75 years old
• Not up-to-date with screening, defined based on an existing electronic health record (EHR)-based flag that indicates absence of FIT within the last 12 months, colonoscopy within the last 10 years, sigmoidoscopy within the last 5 years or multi-target stool DNA (Cologuard) test within 3 years.
• Attending primary care visits during the 2 months of recruitment. According to routine practice, screening status will be confirmed by primary care providers as part of routine visits.
• Being provided the informed consent form.

You may not qualify if…

• Personal history of colorectal cancer (CRC), adenomas, or other related cancers.
• Prior history of colorectal surgery
• Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age.
• Up-to-date with colorectal cancer screening, defined as:
• Fecal occult blood test (FOBT) or FIT within the last 12 months
• FIT-DNA (Cologuard) or FIT-RNA (Colosense) test within 3 years
• cfDNA (Shield) within the last year
• CT colonography within the last 5 years
• Sigmoidoscopy within the last 5 years
• Colonoscopy within the last 10 years
• Abnormal FIT, FOBT, cfDNA, FIT-DNA, or FIT-RNA test within the last 3 years.
• Personal history of any of the following high-risk conditions for colorectal cancer:
• Inflammatory Bowel Disease (IBD), including chronic ulcerative colitis (CUC) and Crohn's disease
• Familial adenomatous polyposis (FAP)
• Other hereditary cancer syndromes including but not limited to:
• Hereditary non-polyposis colorectal cancer syndrome (HNPCC) or "Lynch Syndrome", Peutz-Jeghers Syndrome, MUTYH Polyposis (MAP), Familial Adenomatous Polyposis (FAP), Cowden's Syndrome, Juvenile Polyposis, Serrated Polyposis Syndrome
• Uninsured patients will be excluded because of inability to ensure follow up. Because of recently expanded Medi-Cal eligibility, exclusions due to insurance are expected to be minimal.

Where it is running

• Family Health Centers of San Diego, Logan Heights site — San Diego, California, United States

Full record on ClinicalTrials.gov

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