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

400 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Cologuard and Fecal Immunochemical Test for Colorectal Cancer Screening?

Research shows that the Cologuard test, which looks for DNA changes in stool, is effective for colorectal cancer screening. The Fecal Immunochemical Test (FIT) is also effective, but its success depends on people using it every year. ^{1 2 3 4 5}

Is the Fecal Immunochemical Test (FIT) safe for humans?

The research articles do not provide specific safety data for the Fecal Immunochemical Test (FIT), but it is widely used for colorectal cancer screening, suggesting it is generally considered safe for human use. ^{2 3 5 6 7}

How does the Cologuard treatment differ from other colorectal cancer screening methods?

Cologuard is unique because it combines DNA testing with a stool sample to detect colorectal cancer, unlike the Fecal Immunochemical Test (FIT) which only detects blood in the stool. This makes Cologuard potentially more comprehensive in identifying cancerous and pre-cancerous conditions. ^{3 8 9 10 11}

Research Team

Joshua Demb, PhD, MPH

Principal Investigator

University of California, San Diego

Eligibility Criteria

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 colon issues like IBD, polyps, or colon cancer before.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Factors Affecting Adherence in a Pragmatic Trial of Annual Fecal Immunochemical Testing for Colorectal Cancer. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Results of Compliant Participation in Five Rounds of Fecal Immunochemical Test Screening for Colorectal Cancer. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Factors associated with use and non-use of the Fecal Immunochemical Test (FIT) kit for Colorectal Cancer Screening in Response to a 2012 outreach screening program: a survey study. [2022]

4. Spain pubmed.ncbi.nlm.nih.gov

A systematic review of the clinical validity of the Cologuard™ genetic test for screening colorectal cancer. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Participation, yield, and interval carcinomas in three rounds of biennial FIT-based colorectal cancer screening. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Attendance and yield over three rounds of population-based fecal immunochemical test screening. [2022]

7. Singapore pubmed.ncbi.nlm.nih.gov

Age, male sex, smoking and metabolic syndrome as risk factors of advanced colorectal neoplasia for fecal immunochemical test negative patients. [2022]

8. Egypt pubmed.ncbi.nlm.nih.gov

Positive predictive value of fecal immunochemical test for high-risk colonic adenomas and carcinoma: A health maintenance organization cohort screening study in Lebanon. [2021]

9. England 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Fecal immunochemical test accuracy in average-risk colorectal cancer screening. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Fecal Immunochemical Test: The World's Colorectal Cancer Screening Test. [2021]