Colonoscopy vs FIT Screening for Colorectal Cancer

(CONFIRM Trial)

Recruiting at 45 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Colorectal cancer, Inflammatory bowel disease, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 years

50126 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two methods for colorectal cancer screening in people aged 50-75. One method uses a camera to find and remove precancerous growths, while the other checks for hidden blood in stool. The study aims to see which method better reduces cancer deaths over time.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. You will complete a medication questionnaire before randomization, but there is no mention of a requirement to stop any medications.

What data supports the effectiveness of the treatment Colonoscopy, Colon Examination, Lower GI Endoscopy, FIT, Fecal Immunochemical Test, iFOBT, Hemmocult Test for colorectal cancer screening?

Research shows that the fecal immunochemical test (FIT) is effective in detecting colorectal cancer and is increasingly used over older tests. It has advantages in detecting human blood in stool, which helps in early cancer detection and prevention. ^{1 2 3 4 5}

How does the treatment of Colonoscopy vs FIT Screening for Colorectal Cancer differ from other treatments?

Colonoscopy is a direct visual examination of the colon, while the Fecal Immunochemical Test (FIT) is a non-invasive test that detects hidden blood in stool, which can be an early sign of colorectal cancer. FIT is easier to administer at home and can increase screening rates, but it requires follow-up colonoscopy if results are positive. ^{5 6 7 8 9}

Research Team

Jason A. Dominitz, MD MHS

Principal Investigator

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Douglas J Robertson, MD MPH

Principal Investigator

White River Junction VA Medical Center, White River Junction, VT

Eligibility Criteria

This trial is for men and women aged 50-75, preferably veterans, who can consent to the study. It's not for those with severe health issues that make screening risky or unnecessary, pregnant individuals, people without a stable address, or anyone with a recent history of colon disease or tests.

Inclusion Criteria

Veteran

Able to provide informed consent

I am between 50 and 75 years old.

Exclusion Criteria

I have a history of colon issues like IBD, polyps, cancer, or surgery.

Prisoner

Participation in a concurrent interventional study pertaining to the colon or rectum (including studies of colonoscopy or colorectal cancer screening. Waivers to this exclusion criteria can be requested and granted with the approval of the CONFIRM study co-chairs, the Cooperative Study Program and the leadership of the other study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2.5 years

Treatment

Participants are randomized to either a one-time colonoscopy or annual FIT screening

10 years

Annual visits for FIT group, one-time visit for colonoscopy group

Follow-up

Participants are monitored for colorectal cancer mortality and incidence

10 years

Treatment Details

Interventions

• Colonoscopy
• FIT

Trial Overview The CONFIRM trial is comparing two colorectal cancer screening methods: annual fecal immunochemical tests (FIT) and colonoscopy. The goal is to see which method better reduces death from this cancer over ten years in people at average risk.

Participant Groups

Group I: Arm 2 Experimental Treatment 1 Intervention

FIT (annually)

Group II: Arm 1 Experimental Treatment 1 Intervention

Colonoscopy (one time screening)

Colonoscopy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in United States as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Canada as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Japan as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in China as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Approved in Switzerland as Colonoscopy for:

• Colorectal cancer screening
• Polyp removal
• Investigation of lower gastrointestinal symptoms

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

A screening program using immunochemical fecal occult blood tests (FIT) in Northern Italy significantly reduced colorectal cancer (CRC) incidence and mortality, with a 10% decrease in cumulative incidence and a 27% decrease in incidence-based mortality over the study period.

Approximately 70% of the invited population participated in the screening, leading to the detection of 2896 cancers, which highlights the effectiveness of organized screening programs in early cancer detection and prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. Giorgi Rossi, P., Vicentini, M., Sacchettini, C., et al.[2022]

The fecal immunochemical test (FIT) is increasingly favored over the traditional fecal occult blood test (FOBT) for colorectal cancer screening due to its direct measurement of human hemoglobin in stool, which enhances its effectiveness in detecting colorectal neoplasia.

Current evidence supports the use of FIT as a reliable screening method, leading to the development of guidance statements and quality metrics for its implementation in colorectal cancer prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Robertson, DJ., Lee, JK., Boland, CR., et al.[2022]

The fecal immunochemical test (FIT) is increasingly favored over the traditional fecal occult blood test (FOBT) for colorectal cancer screening due to its direct measurement of human hemoglobin in stool, which enhances its effectiveness in detecting colorectal neoplasia.

Current evidence supports the use of FIT as a reliable screening method for colorectal cancer, leading to the development of guidance statements and quality metrics for its implementation in screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Robertson, DJ., Lee, JK., Boland, CR., et al.[2022]

Fecal immunochemical tests (FITs) showed significantly higher sensitivity for detecting colorectal cancer and significant precursor lesions compared to the older guaiac-based fecal occult blood test (Hemoccult II), with sensitivities of 23.2% for both FITs tested.

Using a single-day stool collection strategy reduced false-positive rates for all tests without significantly impacting their sensitivity, suggesting it could improve compliance in colorectal cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The sensitivity and specificity of guaiac and immunochemical fecal occult blood tests for the detection of advanced colonic adenomas and cancer. Wong, CK., Fedorak, RN., Prosser, CI., et al.[2021]

References

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

Impact of Screening Program on Incidence of Colorectal Cancer: A Cohort Study in Italy. [2022]

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

Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. [2022]

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

Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. [2022]

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

Strategies to Improve Follow-up After Positive Fecal Immunochemical Tests in a Community-Based Setting: A Mixed-Methods Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Transition to quantitative faecal immunochemical testing from guaiac faecal occult blood testing in a fully rolled-out population-based national bowel screening programme. [2021]

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

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

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

Low Literacy Level Instructions and Reminder Calls Improve Patient Handling of Fecal Immunochemical Test Samples. [2021]

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

Association Between Time to Colonoscopy After a Positive Fecal Test Result and Risk of Colorectal Cancer and Cancer Stage at Diagnosis. [2022]

9. Germany pubmed.ncbi.nlm.nih.gov

The sensitivity and specificity of guaiac and immunochemical fecal occult blood tests for the detection of advanced colonic adenomas and cancer. [2021]