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Cancer Screening Test

Cologuard vs FIT for Colorectal Cancer

N/A

Recruiting

Led By Joshua Demb, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults ages 45-49 with EHR documentation indicating that the patient has an assigned primary care provider at UCSD Health

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 3 months of randomization

Awards & highlights

No Placebo-Only Group

Summary

"This trial will compare two stool-based screening tests, Cologuard and the fecal immunochemical test (FIT), in adults aged 45-49 at the University of California San Diego Health system

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since both Cologuard and FIT are non-invasive stool-based tests, they typically do not cause direct side effects. However, an abnormal result may lead to further diagnostic procedures like colonoscopy which carry their own risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ within 3 months of randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~within 3 months of randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months of randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of Abnormal stool blood test results

Proportion of Colorectal cancer screening completion

Proportion of Follow-up colonoscopy after abnormal stool blood test result

Secondary study objectives

Number of Adenomas detected

Number of colorectal cancer cases detected

Number of participants opting out of the pilot

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Mailed Cologuard OutreachExperimental Treatment1 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 OutreachActive Control1 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.

0 / 1Eligibility criteria met