Colonoscopy vs FIT Screening for Colorectal Cancer

(CONFIRM Trial)

Not currently recruiting at 47 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of screening for colorectal cancer: colonoscopy and FIT (a stool test). The goal is to determine which method more effectively prevents deaths from colorectal cancer over 10 years. Colonoscopy is a one-time procedure that allows doctors to see inside the colon, while FIT is a yearly, simple at-home test that checks for hidden blood in the stool. The study seeks veterans aged 50 to 75 who haven't had a colonoscopy in the last 10 years or a stool test in the last year and who do not have symptoms or a family history indicating a higher risk of colorectal cancer. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance future screening methods.

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 prior data suggests that these screening methods are safe for colorectal cancer detection?

A previous study found that serious complications from colonoscopy, such as significant bleeding, are rare. On average, about 17.5 serious bleeding incidents occur for every 10,000 colonoscopies. Although colonoscopy is invasive, it allows doctors to examine the colon and remove suspicious growths.

Research has shown that the FIT (fecal immunochemical test) is well-tolerated and effective at detecting signs of colorectal cancer. As a non-invasive test, it does not involve instruments entering the body, making it easier for many people. Regular use of FIT has been shown to effectively reduce deaths from colorectal cancer.

Both tests offer benefits and potential drawbacks, but they are generally considered safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it directly compares two screening methods for colorectal cancer: colonoscopy and FIT (Fecal Immunochemical Test). While colonoscopy is a one-time, more invasive procedure that allows for direct visualization and removal of polyps, FIT is a non-invasive test that can be done annually at home to detect hidden blood in stool, which may indicate cancer. This trial could clarify which method is more effective or preferable for different patients, potentially leading to more personalized screening strategies. Understanding the strengths and limitations of each approach can help improve early detection and prevention of colorectal cancer.

What evidence suggests that this trial's treatments could be effective for colorectal cancer screening?

This trial will compare colonoscopy with the fecal immunochemical test (FIT) for colorectal cancer (CRC) screening. Studies have shown that both methods effectively screen for CRC. Participants in one arm of this trial will undergo a one-time colonoscopy. Research indicates that colonoscopy can reduce the risk of developing CRC by allowing doctors to find and remove growths that could become cancerous. One study found that people who had colonoscopy screenings had a lower chance of getting CRC and dying from it. Participants in the other arm will use FIT annually. This non-invasive test is better than older tests at detecting blood in the stool, a potential cancer sign. FIT is considered a good option for detecting CRC, especially because it is easy for people to use at home. Both methods have shown promise, but their effectiveness can depend on how often they are used. ^{1 4 6 7 8}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/colorectal-cancer-screening

Recommendation: Colorectal Cancer: Screening After 2 to 9 rounds of biennial gFOBT screening, colorectal cancer mortality was found to be lower at 11 to 30 years of follow-up (relative risk ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815644

Effectiveness of Colonoscopy Screening vs Sigmoidoscopy ... This comparative effectiveness simulation study of 358 204 adults showed a statistically significant 7 percentage point reduction in colorectal cancer ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/search/research-news/17340

New study examines the effectiveness of colonoscopies | CNN Colonoscopy and sigmoidoscopy were associated with a reduced incidence of cancer of the distal colorectum; colonoscopy was also associated with a modest ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2208375

Effect of Colonoscopy Screening on Risks of Colorectal ... In this randomized trial, the risk of colorectal cancer at 10 years was lower among participants who were invited to undergo screening colonoscopy.

5. gastrojournal.org gastrojournal.org/article/S0016-5085(24)00293-2/fulltext

Comparative Effectiveness and Cost-Effectiveness of ... CMSmin reduced CRC incidence by 40% and CRC mortality by 52% vs no screening. These reductions were less profound than the 68%–79% and 73%–81%, respectively, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3584835/

Colonoscopy for Colorectal Cancer Screening - PMC Early reports suggested that colonoscopic screening imparted a 90% risk reduction for colorectal cancer. Subsequent studies showed that estimate to be overly ...

7. giejournal.org giejournal.org/article/S0016-5107(24)03164-X/fulltext

Quality indicators for colonoscopy High-quality colonoscopy includes adequate bowel preparation, safe colonoscope insertion to the proximal extent of the colon, detailed ...

8. aetna.com aetna.com/cpb/medical/data/500_599/0516.html

Colonoscopy and Colorectal Cancer Screening As a part of the screening process, the ACS recommends that all positive results on noncolonoscopy screening tests should be followed up with timely colonoscopy ...