Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

Comparative Effectiveness Pilot Trial of Mailed Cologuard Outreach to Mailed FIT Outreach

The objective of this pilot study is to compare the effectiveness of mailed outreach of two stool based tests, 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: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Diagnostic test: Cologuard; Diagnostic test: Fecal Immunochemical Test

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 3 months will be measured as the primary outcome, in addition to secondary recruitment and intervention-based feasibility outcomes to demonstrate the potential for a larger randomized controlled trial.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92126
      • University of California San Diego

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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.
Active Comparator: 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.; Other Names: OC-Sensor Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Completing Colorectal Cancer Screening	The number of participants who complete any colorectal cancer screening test recommended by US Preventive Services Task Force (colonoscopy, FIT, Cologuard, Sigmoidoscopy or CT Colonography)	Within 3 months of randomization
Number of Participants With Abnormal Stool Blood Test Results	Among those completing designed interventions (Cologuard or FIT), the number of participants with test results yielding an abnormal result.	Within 3 months of randomization
Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result	Among those with positive stool blood test results, the number of participants who complete diagnostic follow-up colonoscopy	Within 6 months after stool blood test completion
Number of Participants With Assigned Screening Test Successfully Ordered	Number of randomized participants for whom the assigned screening test order was successfully placed within the study period.	Within 3 months of randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Opting Out of the Pilot	Measurement of feasibility of pilot to retain participants for the duration of study follow-up	Within 3 months of randomization
Number of Adenomas Detected	Number of participants with adenomas detected during study period	Within 6 months after screening test completion
Number of Sessile Serrated Lesions Detected	Number of participants with sessile serrated lesions detected during study period	Within 6 months after screening test completion
Number of Participants With Colorectal Cancer Detected	Number of participants diagnosed with colorectal cancer during the study period	Within 6 months after screening test completion
Number of Participants With Undeliverable FIT or Cologuard Tests (Mail Fail Rate)	The number of participants who consented to participate who were intended to be mailed a FIT or Cologuard test, but the test was found to be undeliverable.	Within 3 months of randomization

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who do Not Consent to Participate	Measurement of opt-in strategy prior to randomization to determine feasibility of recruitment strategy	Within one month of invitation

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Investigators: Principal Investigator: Joshua Demb, PhD, Postdoctoral Researcher

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 7, 2023
• First Posted (Actual): December 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: early detection; screening; stool blood test
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 803124

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