Head to Head Trial of Mailed Cologuard to Mailed FIT

University of California San Diego

Status: Invitation-only

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

Treatments: Diagnostic Test: Fecal Immunochemical Test; Diagnostic Test: Cologuard

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06931860

4R00CA267181-03 (U.S. NIH Grant/Contract)

R00CA267181 (U.S. NIH Grant/Contract)

80312400

Details and patient eligibility

About

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.

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 45 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Mailed Cologuard Outreach

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Cologuard

Mailed Fecal immunochemical test Outreach

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Fecal Immunochemical Test