Clinical trial NCT06931860: Head to Head Trial of Mailed Cologuard to Mailed FIT
Official title: Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer Screening
Fecal Immunochemical Test
Multi-target Stool DNA
Colorectal Cancer (CRC)
Keywords: screening
early detection
colorectal cancer
stool blood test
mailed outreach
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-04-17
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm intervention trial comparing mailed Cologuard outreach (Intervention 1) to mailed FIT outreach (Intervention 2)
Primary purpose: SCREENING

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 screening eligible adults ages 45-49 receiving care at the University of California San Diego Health system.

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 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.

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

Primary outcomes:
measure: Proportion of Colorectal cancer screening completion
timeFrame: Within 12 months of randomization
Secondary outcomes:
measure: Proportion of Abnormal stool blood test results
timeFrame: Within 12 months of randomization
measure: Proportion of Follow-up colonoscopy after abnormal stool blood test result
timeFrame: Within 24 months after randomization
measure: Colorectal cancer incidence
timeFrame: Within 24 months after randomization
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Joshua Demb, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: