Head to Head Trial of Mailed Cologuard to Mailed FIT
Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach
3 other identifiers
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2025
CompletedFirst Posted
Study publicly available on registry
April 17, 2025
CompletedStudy Start
First participant enrolled
September 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
September 9, 2025
September 1, 2025
12 months
April 9, 2025
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of Colorectal cancer screening completion
The proportion of individuals who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)
Within 12 months of randomization
Secondary Outcomes (3)
Proportion of Abnormal stool blood test results
Within 12 months of randomization
Proportion of Follow-up colonoscopy after abnormal stool blood test result
Within 24 months after randomization
Colorectal cancer incidence
Within 24 months after randomization
Study Arms (2)
Mailed Cologuard Outreach
EXPERIMENTALReceipt 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.
Mailed Fecal immunochemical test Outreach
EXPERIMENTALReceipt 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.
Interventions
Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California San Diego
La Jolla, California, 92093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joshua Demb, PhD, MPH
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
April 9, 2025
First Posted
April 17, 2025
Study Start
September 5, 2025
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
September 1, 2027
Last Updated
September 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share
Data being used for this project involves protected health information that requires special training and completion of research proposals, IRB applications and data use requests directly with University of California San Diego Health System to obtain access. Therefore, we do not anticipate creating unique data resources as part of this study. If researchers receive permission via IRB applications and data use requests to work with these data, we will make available individual-level scientific data used in our study. The rationale is based on restrictions put forth as part of our Institutional Review Board (IRB) protocol and the need to protect study participants from risks associated with their participation. Specifically, our study outlines that data access will be limited to study personnel and will only be accessible for those individuals who have IRB-required training with access to a secure HIPAA research server.