Cologuard vs FIT for Colorectal Cancer Screening

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 aims to compare two tests, Cologuard and the fecal immunochemical test (FIT), to determine which is more effective for screening colorectal cancer. Both tests are sent to participants' homes, allowing them to collect a stool sample and mail it back for analysis. The trial seeks individuals aged 45-49 who receive healthcare at UCSD and have not had a recent colorectal cancer screening. Participants should reside in San Diego or Imperial County and have health insurance. Those with certain bowel diseases or surgeries may not qualify for this trial. As an unphased trial, this study offers participants the chance to contribute to important research that may enhance early detection of colorectal cancer.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

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

Research shows that Cologuard is generally easy to use. In a study with 10,000 participants, Cologuard detected 92% of colon cancers. The FDA has approved it for screening adults for colorectal cancer, indicating its safety.

Studies have shown that the Fecal Immunochemical Test (FIT) is also safe and painless. This test checks for small amounts of blood in stool, which can indicate colorectal cancer. FIT is commonly used in regular screenings, and most people tolerate it well.

Both tests have been used in many screenings without major safety issues. Participants often find them easy to perform at home. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cologuard and Fecal Immunochemical Test (FIT) because these screening methods for colorectal cancer offer unique benefits. Unlike traditional colonoscopy, which is invasive and requires a visit to a medical facility, both Cologuard and FIT can be done at home with a simple sample collection process. Cologuard is distinctive because it combines DNA analysis with fecal blood detection, potentially identifying cancerous changes earlier than standard tests. FIT, on the other hand, is focused on detecting blood in the stool, which can be a sign of cancer or large polyps, and it requires annual testing, providing frequent monitoring. This trial aims to see which test might be more effective or preferable for patients, potentially enhancing early detection and convenience in colorectal cancer screening.

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. Studies have shown that Cologuard accurately detects colorectal cancer, correctly identifying 95% of people with the disease and 94% of those without it. This demonstrates its effectiveness in detecting both the presence and absence of cancer. Research has also linked Cologuard to a significant reduction in cancer cases and deaths, contributing to lives saved. Meanwhile, large studies have shown that FIT effectively reduces deaths from colorectal cancer and is widely used and respected in cancer screening. Both tests are strong tools for early detection, which is crucial for successful treatment. Participants in this trial will receive either the Cologuard test or the FIT as part of the study's separate treatment arms. ^{2 6 7 8 9}

Who Is on the Research Team?

Joshua Demb, PhD, MPH

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

This trial is for adults aged 45-49 who are patients at the University of California San Diego Health system and have not been screened for colorectal cancer. The study aims to compare two types of stool-based tests sent by mail.

Inclusion Criteria

At least one UCSD Health System health visit within the last year

Resides in San Diego or Imperial County

Currently not up to date with CRC screening

Exclusion Criteria

Up-to-date with screening

Lack of health insurance

I have had surgery to remove part or all of my colon.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Test Mailing

Participants are randomized to receive either a mailed Cologuard test or a mailed FIT test for colorectal cancer screening

12 months

Mailed test, no in-person visits required

Follow-up

Participants are monitored for colorectal cancer screening completion and follow-up colonoscopy uptake after abnormal test results

24 months

What Are the Treatments Tested in This Trial?

Interventions

• Cologuard
• Fecal Immunochemical Test

Trial Overview The effectiveness of two mailed stool-based screening tests for colorectal cancer is being compared: Cologuard, which checks for multiple markers in the DNA, and FIT, which looks for blood in the stool.

How Is the Trial Designed?

Group I: Mailed Fecal immunochemical test Outreach Experimental Treatment 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.

Group II: 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.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Fecal immunochemical testing (FIT) is an effective screening method for colorectal cancer, but an abnormal result requires follow-up colonoscopy, which not all patients complete.

A new risk prediction model was successfully redeveloped for a specific health center, identifying patients unlikely to follow up on abnormal FIT results, although the original model did not recalibrate well in a different setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The recalibration and redevelopment of a model to calculate patients' probability of completing a colonoscopy following an abnormal fecal test. Petrik, AF., Johnson, ES., Slaughter, M., et al.[2023]

The fecal immunochemical test (FIT) is a highly sensitive tool for colorectal cancer screening, outperforming older guaiac tests by detecting hemoglobin more effectively, which allows for screening with just one stool sample per cycle.

FIT's growing use in both individual and programmatic settings highlights its potential for improving colorectal cancer detection and monitoring, making it a valuable option for public health initiatives.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fecal Immunochemical Test: The World's Colorectal Cancer Screening Test. Robertson, DJ., Selby, K.[2021]

Citations

1. 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 ...

2. 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 ...

3. 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.

4. journals.lww.com journals.lww.com/ajg/fulltext/2017/10001/outcomes_of_cologuard_screening_at_an_academic.230.aspx

Outcomes of Cologuard Screening at an Academic Medical... A positive result was seen in 12.5% of patients who completed the test, and there was a false positive rate of 17.9%. Advanced adenomas were seen in 7 patients.

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. cms.gov cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&NCAId=277

Screening for Colorectal Cancer - Stool DNA Testing Cologuard™ is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard™ is not a replacement for ...

8. 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 ...

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.