CompletedNot Applicable

Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

United States12 participantsStarted 2024-05-15

Plain-language summary

The objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, Cologuard and the fecal immunochemical test (FIT) in screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.

Who can participate

Age range

45 Years – 49 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health * ≥1 UCSD Health System health visit within the last year * Resides in San Diego or Imperial County * Currently not up to date with CRC screening * Insured by private, public or other health insurance. Exclusion Criteria: * Up-to-date with screening * Prior history of colonic disease, including inflammatory bowel disease, one or more colorectal neoplastic polyps (i.e., adenomas) or colorectal cancer. * Prior history of colectomy * Lack of health insurance

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants Completing Colorectal Cancer Screening

Timeframe: Within 3 months of randomization

Number of Participants With Abnormal Stool Blood Test Results

Timeframe: Within 3 months of randomization

Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result

Timeframe: Within 6 months after stool blood test completion

Number of Participants With Assigned Screening Test Successfully Ordered

Timeframe: Within 3 months of randomization

Trial details

NCT IDNCT06173375

SponsorUniversity of California, San Diego

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

Results submitted2026-02-06

View on ClinicalTrials.gov More Colorectal Cancer trials

Who can participate

Age range

45 Years – 49 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of Participants Completing Colorectal Cancer Screening

Timeframe: Within 3 months of randomization

Number of Participants With Abnormal Stool Blood Test Results

Timeframe: Within 3 months of randomization

Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result

Timeframe: Within 6 months after stool blood test completion

Number of Participants With Assigned Screening Test Successfully Ordered

Timeframe: Within 3 months of randomization