FIT vs Cologuard Tests for Colorectal Cancer Screening
(CARES Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two at-home colorectal cancer screening tests, FIT (Fecal Immunochemical Test) and Cologuard, to determine which one participants are more likely to complete. The researchers aim to identify which test is easier and more convenient for patients at community health centers. Participants will receive one of these tests by mail, complete it at home, and return it to evaluate which method proves more effective. Eligible participants have visited a participating community clinic in the last two years and have not had recent colorectal screenings, such as a FIT test in the past year or a colonoscopy in the past ten years. As an unphased trial, this study allows participants to contribute to research that could enhance the convenience of colorectal cancer screening for many people.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that both Cologuard and FIT kits are generally safe for colorectal cancer screening. Cologuard detects DNA markers in stool and, in a study with 10,000 participants, detected 92% of colon cancers. Its safety is well-documented, and the FDA has approved it for this purpose.
The FIT kit, another common test, checks for hidden blood in stool. It is used worldwide and is known for its safety and ease of use. This simple test can be done at home without discomfort.
Both tests are designed for home use, with no serious side effects reported. Participants in past studies have handled both tests well, making them reliable screening options.12345Why are researchers excited about this trial?
Researchers are excited about the FIT and Cologuard tests for colorectal cancer screening because they offer convenient, at-home testing options that could increase screening rates. Unlike traditional colonoscopies, which require an in-person procedure, both the FIT and Cologuard tests are non-invasive and can be completed at home with a simple mail-in process. The Cologuard test is particularly unique because it combines stool DNA testing with a fecal immunochemical test, potentially improving accuracy in detecting cancerous and precancerous conditions. These features make these tests appealing alternatives to more invasive screening methods, possibly leading to earlier detection and better outcomes.
What evidence suggests that this trial's treatments could be effective for colorectal cancer screening?
This trial will compare the effectiveness of the Cologuard test and the FIT (Fecal Immunochemical Test) for colorectal cancer screening. Research has shown that the Cologuard test is highly effective, correctly identifying 95% of actual cancer cases (sensitivity) and accurately identifying 94% of non-cancer cases (specificity). It has also been linked to a 76% reduction in deaths from colorectal cancer. Meanwhile, large population studies have demonstrated that the FIT effectively reduces deaths from colorectal cancer. Although less evidence exists about its effectiveness compared to Cologuard, it is widely used and considered reliable for detecting colorectal cancer. Both tests are noninvasive and have proven useful in different settings. Participants in this trial will receive either the Cologuard test or the FIT kit as part of their screening process.36789
Who Is on the Research Team?
Jennifer Haas, MD
Principal Investigator
Massachusetts General Hospital
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive either a mailed FIT kit or a Cologuard test to complete at home and mail back
Follow-up
Participants are monitored for completion of the stool-based screening test and diagnostic colonoscopy if needed
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
A FIT kit mailed to the patient's home
A Cologuard test mailed to the patient's home
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
University of California, Los Angeles
Collaborator
Stand Up To Cancer
Collaborator
Great Plains Tribal Leaders Health Board
Collaborator
Citations
1.
exactsciences.com
exactsciences.com/newsroom/press-releases/new-study-in-journal-of-the-national-cancer-institute-finds-cologuard-plusNew 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 ...
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.
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 ...
Cologuard test
It can detect both precancer and cancer. Learn more. How effective is the Cologuard test? Cologuard found 92% of all colon cancers (and 94% of all stage I ...
5.
investor.exactsciences.com
investor.exactsciences.com/investor-relations/press-releases/press-release-details/2025/Exact-Sciences-Launches-the-Cologuard-Plus-Test-Transforming-Colorectal-Cancer-Screening/default.aspxExact Sciences Launches the Cologuard Plus™ Test ...
The Cologuard Plus test demonstrated 95% sensitivity for colorectal cancer detection at 94% specificity, making it the most accurate noninvasive CRC screening ...
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 ...
Summary of Safety and Effectiveness Data (SSED)
Cologuard involves stool DNA-based (sDNA) testing, which detects molecular markers of altered DNA that are contained in the cells shed by CRC or ...
Accuracy, Sensitivity, and Specificity - Cologuard
The Cologuard Plus™ test has a 95% CRC sensitivity and a 94% specificity (adjusted to average-risk patients aged 45-75 years). For adults 45+ At Avg. Risk.
Cologuard® Clinician Brochure
The results of the study demonstrated the safety and effectiveness of the. Cologuard test as a screening test for the detection of markers associated with the ...
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