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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two stool-based tests, Cologuard and the fecal immunochemical test (FIT), to determine which better screens for colorectal cancer. The goal is to identify the more effective test when mailed to individuals not current with their screenings. Eligible participants are adults aged 45-49 who receive care at UCSD Health, have visited in the last year, and live in San Diego or Imperial County. Participants must not have a history of certain bowel diseases or prior colorectal cancer. The study is open to those with health insurance who haven't had a recent screening.

As an unphased trial, this study allows participants to contribute to important research that could enhance colorectal cancer screening methods.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both Cologuard and the Fecal Immunochemical Test (FIT) are safe options for detecting colorectal cancer.

Research indicates that Cologuard is easy to use and has not caused any serious side effects in clinical trials. The main risk is that the test might not detect all cancers or might mistakenly identify non-cancerous conditions as cancer.

The FIT is also considered safe and painless. It detects hidden blood in stool, which could indicate colorectal cancer. There are no major safety concerns with this test.

Both tests have been approved for regular use, confirming their safety for everyday medical practice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing Cologuard and the Fecal Immunochemical Test (FIT) for colorectal cancer screening because these methods offer unique benefits. Unlike traditional colonoscopies, which can be invasive and require a visit to a medical facility, both Cologuard and FIT can be completed at home with no need for special preparation. Cologuard stands out because it combines DNA analysis with the detection of blood in the stool, potentially offering a more comprehensive screening every three years, compared to FIT's annual screening based solely on detecting blood. This trial aims to determine which method is more effective at catching cancer early, which could lead to more personalized and comfortable screening options for patients in the future.

What evidence suggests that this trial's treatments could be effective for colorectal cancer screening?

This trial will compare the effectiveness of Cologuard and the fecal immunochemical test (FIT) for colorectal cancer screening. Research has shown that Cologuard effectively detects colorectal cancer (CRC), correctly identifying 95% of CRC cases, a sensitivity of 95%. It also accurately rules out CRC in 94% of people without the disease, a specificity of 94%. Additionally, studies have demonstrated that Cologuard lowers the chances of developing CRC by 68% and reduces deaths from CRC by 76%.

FIT, another screening option in this trial, is widely used and known for its ability to detect advanced abnormal tissue growth. Evidence suggests that FIT is a trusted tool in CRC screening programs, providing reliable results for early detection. Both tests play a crucial role in early CRC detection, which is vital for effective treatment. ^{2 6 7 8 9}

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+

Citations

1. exactsciences.com exactsciences.com/newsroom/press-releases/new-study-in-journal-of-the-national-cancer-institute-finds-cologuard-plus

New Study in Journal of the National Cancer Institute Finds ... With a sensitivity of 95% for CRC and specificity of 94% in the U.S. screening age population, Cologuard Plus offers high performance in a ...

2. cologuardhcp.com cologuardhcp.com/patient-outcomes/improved-outcomes

Cologuard-first screening can help save more lives 1,2 The Cologuard® test demonstrated 68% reduction in CRC incidence and 76% reduction in mortality. For adults 45+ At Avg. Risk. Rx Only. See Risk Info.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12517030/

Improving colorectal cancer screening through Cologuard ... Cologuard completion rates improved from a preintervention median of 7.38%–10.00%. Median order rates rose from 14.59% to 18.71%, and overall ...

4. exactsciences.com exactsciences.com/newsroom/press-releases/new-modeling-data-show-the-cologuard-test-has-detected-more-than-623-000-cancers-and-precancers

New Modeling Data Show the Cologuard® Test Has ... 80% of cancers detected by the Cologuard test were early-stage cancers. ·42,000 people were identified to have stage I. By detecting cancer ...

5. cologuard.com cologuard.com/

Cologuard® and Cologuard Plus™ Colon Cancer Screening ... Cologuard found 92% of all colon cancers (and 94% of all stage I & II cancers) in a clinical study of 10,000 participants, ages 50-84 years old, who are of ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/P230043B.pdf

Summary of Safety and Effectiveness Data (SSED) A negative Cologuard Plus test result does not guarantee the absence of cancer or advanced precancerous lesions. Patients with a negative ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf13/p130017b.pdf

Summary of Safety and Effectiveness Data (SSED) Cologuard is intended for the qualitative detection of colorectal neoplasia associated. DNA markers and for the presence of occult hemoglobin in ...

8. cologuard.com cologuard.com/risk-information

Important Risk Information The risks related to using the Cologuard collection kit are low, with no serious adverse events reported among people in a clinical trial.

9. cologuardhcp.com cologuardhcp.com/about/crc-screening-guidelines

CRC Screening Guidelines and Frequency - Cologuard The USPSTF and ACS screening guidelines recommend a 3-year screening interval following a negative Cologuard result. For adults 45+ at Avg. Risk. Rx Only.