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OpenTrials
Enrolling by Invitation

NCT Number: NCT06931860

Head to Head Trial of Mailed Cologuard to Mailed FIT

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.

Enrolling by Invitation

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Key information

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, 92093, 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 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.

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. Colorectal cancer incidence

    Time frame: Within 24 months after randomization

    Number of colorectal cancers detected during study period

Sponsors and collaborators

Lead sponsor

University of California, San Diego

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Comparative Effectiveness of Mailed Cologuard Outreach to Mailed FIT Outreach

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 17, 2025
Registry last updated
Sep 9, 2025

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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