Status:

ENROLLING_BY_INVITATION

Head to Head Trial of Mailed Cologuard to Mailed FIT

Lead Sponsor:

University of California, San Diego

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Colorectal Cancer Screening

Fecal Immunochemical Test

Eligibility:

All Genders

45-49 years

Phase:

NA

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 scree...

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 Cologua...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 5 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

September 1 2027

Estimated Enrollment :

400 Patients enrolled

Trial Details

Trial ID

NCT06931860

Start Date

September 5 2025

End Date

September 1 2027

Last Update

September 9 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

University of California San Diego

La Jolla, California, United States, 92093