Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

Part of paid clinical trials in La Jolla, California.

Sponsor
University of California, San Diego
Study ID
NCT06173375
Status
Completed

Conditions

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 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.

Key Dates

Start date
May 15, 2024
Status verified
Apr 2026
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
12 participants (actual)
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.
  • Active Comparator: 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

Number of Participants Completing Colorectal Cancer Screening [ Time Frame: Within 3 months of randomization ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92126-

Find similar trials in La Jolla, CA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
University of California San Diego· La Jolla, CA

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