Head to Head Trial of Mailed Cologuard to Mailed FIT

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06931860
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
45 Years - 49 Years
Healthy Volunteers
Not accepted

Interventions

  • Cologuard — DIAGNOSTIC_TEST
    Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.
  • Fecal Immunochemical Test — DIAGNOSTIC_TEST
    Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.

Study Details

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.

Key Dates

Start date
Sep 5, 2025
Status verified
Sep 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
400 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Mailed Cologuard Outreach
    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.
  • Experimental: Mailed Fecal immunochemical test Outreach
    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 Measure

Proportion of Colorectal cancer screening completion [ Time Frame: Within 12 months of randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92093-

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By research site
University of California San Diego· La Jolla, CA

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