Head to Head Trial of Mailed Cologuard to Mailed FIT (NCT06931860) | Clinical Trial Compass
By InvitationNot Applicable
Head to Head Trial of Mailed Cologuard to Mailed FIT
United States400 participantsStarted 2025-09-05
Plain-language summary
The objective of this study is to measure the comparative effectiveness of mailed outreach of two stool based tests, multi-target stool DNA (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.
1This trial is comparing two mail-in stool tests — Cologuard and FIT — for colorectal cancer screening. Can you explain the key differences between these two tests in terms of how accurate they are and what happens if one comes back positive?
2Since this study is 'enrolling by invitation,' does that mean it's only open to certain patients, and is there any chance I could be considered for it through your practice?
3The trial is measuring whether people actually complete the screening test when it's mailed to them — does that mean researchers don't yet have strong evidence about which test leads to better follow-through, and how should that uncertainty factor into which test you'd recommend for me right now?
4If I were assigned to one of these tests through the trial but my result came back abnormal, what would the next steps look like, and would my care proceed the same way as if I'd done the test outside of a study?
5Given that standard colorectal cancer screening options like FIT and Cologuard already exist outside this trial, would you recommend I just go ahead with one of those now, or is there a reason it might be worth waiting to see if I qualify for this study?
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
1
Proportion of Colorectal cancer screening completion