Head to Head Trial of Mailed Cologuard to Mailed FIT

September 5, 2025 updated by: Joshua Demb, PhD, MPH, University of California, San Diego

Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mailed Cologuard Outreach
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.
Diagnostic test: Cologuard
Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.
Experimental: Mailed Fecal immunochemical test Outreach
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.
Diagnostic test: Fecal Immunochemical Test
Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Colorectal cancer screening completion
Time Frame: Within 12 months of randomization
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Abnormal stool blood test results
Time Frame: Within 12 months of randomization
Among those completing designed interventions (Cologuard or FIT), the proportion of test results yielding an abnormal result.
Within 12 months of randomization
Proportion of Follow-up colonoscopy after abnormal stool blood test result
Time Frame: Within 24 months after randomization
Among those with positive stool blood test results, the proportion who complete diagnostic follow-up colonoscopy
Within 24 months after randomization
Colorectal cancer incidence
Time Frame: Within 24 months after randomization
Number of colorectal cancers detected during study period
Within 24 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Diego

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Joshua Demb, PhD, MPH, University of California, San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Estimated)

September 9, 2025

Last Update Submitted That Met QC Criteria

September 5, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 80312400
  • R00CA267181 (U.S. NIH Grant/Contract)
  • 4R00CA267181-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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