Cologuard vs FIT for Colorectal Cancer

Overseen By Joshua Demb, PhD, MPH

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Colonic disease, Colectomy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Joshua Demb, PhD

Principal Investigator

Postdoctoral Researcher

Are You a Good Fit for This Trial?

This trial is for adults aged 45-49 who are not current with colorectal cancer (CRC) screening, have a primary care provider at UCSD Health, have had a health visit within the last year, and live in San Diego or Imperial County. They must also be insured.

Inclusion Criteria

You have not had the recommended screening for colorectal cancer.

I am aged 45-49 and have a primary care provider at UCSD Health.

You have health insurance, whether it's from a private or public provider.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive mailed Cologuard or FIT tests for colorectal cancer screening

3 months

Mailed test, no in-person visits required

Follow-up

Participants are monitored for test completion and follow-up colonoscopy if needed

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Cologuard
• Fecal Immunochemical Test

Trial Overview The study is testing the effectiveness of two stool-based CRC screening methods by mailing them to participants: Cologuard and the fecal immunochemical test (FIT). It aims to see which one works better for people receiving care at UCSD Health.

How Is the Trial Designed?

Group I: Mailed Cologuard Outreach Experimental Treatment 1 Intervention

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.

Group II: Mailed Fecal immunochemical test Outreach Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+