Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

NCT06173375 | Completed Results DMC FDA Device

• 1 other identifier: 803124
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Cancer

Keywords

screening; early detection; stool blood test

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Number of Participants Opting Out of the Pilot

  Within 3 months of randomization

• Number of Adenomas Detected

  Within 6 months after screening test completion

• Number of Sessile Serrated Lesions Detected

  Within 6 months after screening test completion

• Number of Participants With Colorectal Cancer Detected

  Within 6 months after screening test completion

• Number of Participants With Undeliverable FIT or Cologuard Tests (Mail Fail Rate)

  Within 3 months of randomization

Other Outcomes (1)

• Number of Participants Who do Not Consent to Participate

  Within one month of invitation

Study Arms (2)

Mailed Cologuard Outreach

EXPERIMENTAL

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

Mailed Fecal immunochemical test Outreach

ACTIVE COMPARATOR

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

Interventions

Cologuard DIAGNOSTIC_TEST

Multi-target stool DNA test for colorectal cancer screening implemented by Exact Sciences. Cologuard has 94% sensitivity and 87% specificity to detect colorectal cancer.

Mailed Cologuard Outreach

Fecal Immunochemical Test DIAGNOSTIC_TEST

Stool blood test for colorectal cancer screening. FIT has 75% sensitivity and 90% specificity to detect colorectal cancer.

Also known as: OC-Sensor Test

Mailed Fecal immunochemical test Outreach

Eligibility Criteria

• Age: 45 Years - 49 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92126, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

This pilot study enrolled a small number of participants relative to those recruited. The requirement for informed consent and HIPAA authorization may have affected recruitment. The limited sample size restricts the ability to draw definitive conclusions and may impact generalizability.

Results Point of Contact

• Title: Joshua Demb
• Organization: University of California San Diego

jdemb@health.ucsd.edu

(858) 822-3747

Study Officials

• Joshua Demb, PhD

  Postdoctoral Researcher

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Postdoctoral Scholar

Model Details: Two-arm intervention trial comparing mailed Cologuard outreach (intervention) to mailed FIT outreach (control)

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 15, 2023
• Study Start: May 15, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: May 12, 2026
• Results First Posted: May 12, 2026

Record last verified: 2026-04

Locations

US (1)