FIT vs Cologuard Tests for Colorectal Cancer Screening

(CARES Trial)

Recruiting at 2 trial locations

Overseen By Jennifer Haas, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Ulcerative colitis, Crohn's disease, Colorectal cancer, others

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

Compensation: Varies

Number of Visits: Unknown

5255 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this pragmatic randomized clinical trial is to compare two colorectal (CRC) screening outreach approaches (FIT and Cologuard) in community health centers (CHC) in patients overdue for CRC screening. The main questions the project aims to answer are: What screening test has a higher completion rate? What screening test is more feasible and acceptable in a CHC setting? Patients will be sent a CRC screening test in the mail and will be asked to complete it at home and mail it back. Researchers will compare the completion rates for each screening test and will also look at the overall completion rate of both tests.

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 seems unlikely that you would need to stop, as the trial involves completing a home screening test for colorectal cancer.

What data supports the effectiveness of the Cologuard and FIT kit screening tests for colorectal cancer?

The Cologuard test is a non-invasive option for colorectal cancer screening that has been reviewed and approved by the FDA, indicating its effectiveness. The FIT test has been shown to reduce the burden of colorectal cancer when used annually, highlighting its role in effective screening. ^{1 2 3 4 5}

Is the Cologuard test safe for humans?

The Cologuard test is a non-invasive stool-based DNA test approved by the FDA for colorectal cancer screening, indicating it has been evaluated for safety in humans. ^{1 2 4 6 7}

How does the Cologuard test differ from other treatments for colorectal cancer screening?

Cologuard is unique because it is a non-invasive stool DNA test that screens for colorectal cancer by detecting specific DNA markers and blood in the stool, offering an alternative to traditional methods like colonoscopy. Unlike the FIT test, which requires annual testing, Cologuard is typically done every three years, providing a less frequent screening option. ^{1 2 3 4 8}

Research Team

Jennifer Haas, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for people aged 45-75 who've visited a participating community clinic in the last two years, are alive, and speak English or Spanish. It's not for those with Ulcerative Colitis, Crohn's disease, existing colorectal cancer, or recent colorectal screening tests.

Inclusion Criteria

I prefer to communicate in English or Spanish.

Has had a visit at a participating community clinic within the last two years

Alive

Exclusion Criteria

I have been diagnosed with Crohn's disease.

I have been diagnosed with colorectal cancer.

I have been diagnosed with Ulcerative Colitis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either a mailed FIT kit or a Cologuard test to complete at home and mail back

6 months

Follow-up

Participants are monitored for completion of the stool-based screening test and diagnostic colonoscopy if needed

6 months

Treatment Details

Interventions

• Cologuard Screening Test
• FIT kit Screening Test

Trial Overview The study compares two at-home CRC screening methods: FIT kit and Cologuard. Sent by mail to participants overdue for CRC screening at community health centers, researchers will see which test has higher completion rates and is more suitable for these settings.

Participant Groups

Group I: Mailed FIT Kit Active Control 1 Intervention

A FIT kit mailed to the patient's home

Group II: Cologuard Active Control 1 Intervention

A Cologuard test mailed to the patient's home

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

University of California, Los Angeles

Collaborator

Trials

1,594

Recruited

10,430,000+

Stand Up To Cancer

Collaborator

Trials

53

Recruited

40,100+

Great Plains Tribal Leaders Health Board

Collaborator

Trials

2

Recruited

5,700+

References

1. England pubmed.ncbi.nlm.nih.gov

Exact Sciences' experience with the FDA and CMS parallel review program. [2019]

2. Spain pubmed.ncbi.nlm.nih.gov

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

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

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

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

Comprehensive Cost Implications of Commercially Available Noninvasive Colorectal Cancer Screening Modalities. [2023]

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

High rate of advanced adenoma detection in 4 rounds of colorectal cancer screening with the fecal immunochemical test. [2022]

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

Emerging stool-based and blood-based non-invasive DNA tests for colorectal cancer screening: the importance of cancer prevention in addition to cancer detection. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Efficacy of cell-free DNA methylation-based blood test for colorectal cancer screening in high-risk population: a prospective cohort study. [2023]

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]