NCT06929481Active, not recruiting
Screening With a DNA Blood Test to Address Colorectal Cancer Inequities
Screening With Liquid Biopsies to Address Colorectal Cancer Inequities
Source: ClinicalTrials.gov · Last updated 26 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 340 (estimated)
- First submitted
- 16 Mar 2025
- Start date
- 28 Apr 2025
- Primary completion date
- Jul 2026
- Lead sponsor
- University of California, San Diego
- Diseases
- Colorectal cancer
- NCT number
- NCT06929481
What you commit to
- Study type: Interventional
- Planned participants: 340
- From 28 Apr 2025 to the primary completion date, Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of colorectal surgery
Other illness
- Personal history of colorectal cancer (CRC), adenomas, or other related cancers.
- 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
- 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
Age
- Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age.
Other
- Abnormal FIT, FOBT, cfDNA, FIT-DNA, or FIT-RNA test within the last 3 years.
- 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.
Who the study is looking for
- 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.
Age in the registry: 45 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Family Health Centers of San Diego, Logan Heights site Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
Related publications
- Blood-based cell-free DNA for addressing colorectal cancer screening disparities: a study protocol for a randomised trial.BMJ Open · 2026 · PMID 42498482
This page is information, not medical advice. Discuss any trial with your doctor.