Blood test may boost colorectal cancer screening in underserved communities
NCT ID NCT06929481
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether offering a blood test (cell free DNA) alongside standard stool tests and colonoscopy increases colorectal cancer screening rates among people who are not up-to-date with screening. The trial enrolls 340 adults aged 45-75 at a health center serving low-income and minority groups. Participants are randomly assigned to receive either standard screening options or expanded options that include the blood test, and researchers will compare how many complete screening within 60 days.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cell free DNA (cfDNA) blood test
- What this could lead to
- If successful, this could show that offering a simple blood test increases colorectal cancer screening rates among groups who currently face barriers, helping reduce health disparities.
- What could go wrong
- This is a small, early-stage pragmatic trial focused on screening completion, not cancer detection or survival. The blood test is less sensitive for advanced polyps than colonoscopy, so it may miss some precancerous growths.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 340 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2025
- Expected to finish
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Jul 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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45 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Persons, aged 45 to 75 years old 2. 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. 3. 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. 4. Being provided the informed consent form. Exclusion Criteria: 1. Personal history of colorectal cancer (CRC), adenomas, or other related cancers. 2. Prior history of colorectal surgery 3. Family history of CRC, defined as having one or more first-degree relative (parent, sibling, or child) diagnosed with CRC at any age. 4. 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 5. Abnormal FIT, FOBT, cfDNA, FIT-DNA, or FIT-RNA test within the last 3 years. 6. 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 7. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Family Health Centers of San Diego, Logan Heights site
San Diego, California, 92113, United States
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Other studies related to the condition(s) this trial covers.
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