Head to Head Trial of Mailed Cologuard to Mailed FIT

Not Applicable

• Conditions: Colorectal Cancer Screening; Fecal Immunochemical Test; Multi-target Stool DNA; Colorectal Cancer (CRC)

• Registration Number: NCT06931860
• Lead Sponsor: University of California, San Diego

Brief 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.

Detailed Description

Adults ages 45-49 who are insured, deemed average risk and not currently up to date with colorectal cancer screening will be enrolled. Eligible participants will be randomized to either mailed Cologuard outreach, facilitated by Exact Sciences or mailed FIT outreach. Colorectal cancer screening completion within 12 months of randomization will be measured as the primary outcome, in addition to secondary outcomes of Cologuard or FIT positivity rate measured within 12 months of randomization, and follow-up colonoscopy uptake and CRC incidence, measured within 24 months of randomization.

Study Timeline

• Status Verified: 2025-04
• Study Start: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Study First Posted: 2025-04-17
• Last Update Posted: 2025-04-17
• Primary Completion: 2026-06
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of Colorectal cancer screening completion	Within 12 months of randomization	The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)

Secondary Outcome Measures

Name	Time	Method
Proportion of Abnormal stool blood test results	Within 12 months of randomization	Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.
Proportion of Follow-up colonoscopy after abnormal stool blood test result	Within 24 months after randomization	Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy
Colorectal cancer incidence	Within 24 months after randomization	Number of colorectal cancers detected during study period

Trial Locations

Locations (1)

University of California San Diego; 🇺🇸 La Jolla, California, United States