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Completed

NCT Number: NCT06173375

Head to Head Pilot Trial of Mailed Cologuard to Mailed FIT

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

45 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California San Diego

La Jolla, California, 92126, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Fecal Immunochemical Test

Diagnostic Test

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

Other names: OC-Sensor Test

Primary outcomes

  1. Number of Participants Completing Colorectal Cancer Screening

    Time frame: Within 3 months of randomization

    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)

  2. Number of Participants With Abnormal Stool Blood Test Results

    Time frame: Within 3 months of randomization

    Among those completing designed interventions (Cologuard or FIT), the number of participants with test results yielding an abnormal result.

  3. Number of Participants Completing Follow-up Colonoscopy After Abnormal Stool Blood Test Result

    Time frame: Within 6 months after stool blood test completion

    Among those with positive stool blood test results, the number of participants who complete diagnostic follow-up colonoscopy

  4. Number of Participants With Assigned Screening Test Successfully Ordered

    Time frame: Within 3 months of randomization

    Number of randomized participants for whom the assigned screening test order was successfully placed within the study period.

Secondary outcomes

  1. Number of Participants Opting Out of the Pilot

    Time frame: Within 3 months of randomization

    Measurement of feasibility of pilot to retain participants for the duration of study follow-up

  2. Number of Adenomas Detected

    Time frame: Within 6 months after screening test completion

    Number of participants with adenomas detected during study period

  3. Number of Sessile Serrated Lesions Detected

    Time frame: Within 6 months after screening test completion

    Number of participants with sessile serrated lesions detected during study period

  4. Number of Participants With Colorectal Cancer Detected

    Time frame: Within 6 months after screening test completion

    Number of participants diagnosed with colorectal cancer during the study period

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

    Time frame: Within 3 months of randomization

    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.

Other outcomes

  1. Number of Participants Who do Not Consent to Participate

    Time frame: Within one month of invitation

    Measurement of opt-in strategy prior to randomization to determine feasibility of recruitment strategy

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Dec 15, 2023
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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