Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

Not Applicable

Active, not recruiting

• Conditions: Colorectal Cancer
• Interventions: Diagnostic Test: Cologuard; Diagnostic Test: Fecal Immunochemical Test

• Registration Number: NCT06173375
• Lead Sponsor: University of California, San Diego

Brief 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.

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 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.

Study Timeline

• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-07
• Study First Posted: 2023-12-15
• Study Start: 2024-05-15
• Primary Completion: 2024-12-31
• Status Verified: 2025-04
• Study Completion: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-13

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Arm && Interventions

Group	Intervention	Description
Mailed Cologuard Outreach	Cologuard	Receipt of mailed Cologuard test for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 3 years. If test is positive, participant will be advised to schedule colonoscopy for further testing.
Mailed Fecal immunochemical test Outreach	Fecal Immunochemical Test	Receipt of mailed FIT for colorectal cancer screening to be completed and returned by participant. If test is negative, participant will be advised to undergo another test in 1 year. If test is positive, participant will be advised to schedule colonoscopy for further testing.

Primary Outcome Measures

Name	Time	Method
Proportion of Colorectal cancer screening completion	Within 3 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)
Proportion of Abnormal stool blood test results	Within 3 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 6 months after stool blood test completion	Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy

Secondary Outcome Measures

Name	Time	Method
Number of participants opting out of the pilot	Within 3 months of randomization	Measurement of feasibility of pilot
Number of participants with undeliverable FIT or Cologuard tests (mail fail rate)	Within 3 months of randomization	Measurement of feasibility of mailed outreach
Number of Adenomas detected	Within 6 months after screening test completion	Measurement of number of adenomas detected during study period
Number of sessile serrated lesions detected	Within 6 months after screening test completion	Measurement of number of sessile serrated lesions detected during study period
Number of colorectal cancer cases detected	Within 6 months after screening test completion	Number of colorectal cancers detected during study period

Trial Locations

Locations (1)

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