Head to Head Trial of Mailed Cologuard to Mailed FIT
Launched by UNIVERSITY OF CALIFORNIA, SAN DIEGO · Apr 9, 2025
Trial Information
Current as of June 26, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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
About University Of California, San Diego
The University of California, San Diego (UCSD) is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a robust focus on translational medicine, UCSD leverages its interdisciplinary approach to explore groundbreaking therapies and interventions across a wide range of medical fields. The university's state-of-the-art facilities and collaboration with top-tier faculty and researchers ensure a comprehensive and ethical framework for conducting clinical trials, ultimately aiming to enhance patient outcomes and contribute to the global body of medical knowledge.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
La Jolla, California, United States
Patients applied
Trial Officials
Joshua Demb, PhD, MPH
Principal Investigator
University of California, San Diego
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported