N/A
Completed N=12
Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT
Colorectal Cancer
Source: ClinicalTrials.gov NCT06173375 ↗
Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2026
Primary outcomePrimary: Number of Participants Completing Colorectal Cancer Screening — 5; 3 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Completing Colorectal Cancer Screening |
5; 3 | — |
| PRIMARY Number of Participants With Abnormal Stool Blood Test Results |
0; 1 | — |
| PRIMARY Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result |
0; 1 | — |
| PRIMARY Number of Participants With Assigned Screening Test Successfully Ordered |
6; 6 | — |
| SECONDARY Number of Participants Opting Out of the Pilot |
0; 0 | — |
| SECONDARY Number of Adenomas Detected |
1; 1 | — |
| SECONDARY Number of Sessile Serrated Lesions Detected |
0; 1 | — |
| SECONDARY Number of Participants With Colorectal Cancer Detected |
0; 0 | — |
| SECONDARY Number of Participants With Undeliverable FIT or Cologuard Tests (Mail Fail Rate) |
0; 0 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT06173375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.