Colonoscopy vs Stool Testing for Colorectal Polyps

(COOP Trial)

Recruiting at 20 trial locations

Overseen By Kelsey M Veilleux, MD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Colorectal cancer, Genetic syndromes, IBD, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 6 years

8946 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for monitoring colorectal polyps, which are growths in the colon that can sometimes become cancerous. It examines whether a yearly stool test (FIT, or Fecal Immunochemical Test) is as effective as periodic colonoscopy (a colon examination). Suitable participants have a history of colorectal polyps, had two or fewer small polyps found on their last colonoscopy, and are due for another colonoscopy soon. Participants must speak English or Spanish and provide written consent to join. The trial aims to determine which method better detects potential problems early. As an unphased trial, it offers participants the opportunity to contribute to important research that could enhance future screening methods for colorectal polyps.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both colonoscopy and FIT (fecal immunochemical testing) have been studied for safety, though they are used and tolerated differently.

A colonoscopy involves a doctor using a camera to examine the inside of the colon. Studies have found that it can sometimes cause side effects. For instance, bleeding occurs more frequently when small growths called polyps are removed—about 8.7 times per 1,000 procedures. Despite these risks, colonoscopy remains an important tool for detecting and preventing colorectal cancer.

FIT, in contrast, is a non-invasive test that checks for blood in the stool, which can indicate cancer. This test is generally easy to tolerate and lacks the risks associated with colonoscopy. Research shows that many people participate in FIT testing, and it has fewer false negatives compared to other stool tests.

Overall, both tests offer advantages and disadvantages, but they are considered safe options for assessing colorectal health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two methods for detecting colorectal polyps: colonoscopy and FIT (Fecal Immunochemical Test). Colonoscopy is a one-time procedure that allows direct visualization and removal of polyps, offering immediate results. In contrast, FIT is a non-invasive, annual stool test that detects hidden blood, which can be an indicator of polyps. This trial aims to find out if the convenience and non-invasiveness of FIT can match the effectiveness of colonoscopy in detecting polyps, potentially offering a more accessible screening option for patients.

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

This trial will compare the effectiveness of colonoscopy and the fecal immunochemical test (FIT) for detecting colorectal polyps. Research has shown that colonoscopies can lower the risk of colorectal cancer. One study found a 7% decrease in colorectal cancer among people who underwent colonoscopies. Another study found that individuals who had a colonoscopy were less likely to develop colorectal cancer over the next 10 years.

Participants in this trial may receive the fecal immunochemical test (FIT), which effectively detects colorectal issues. FIT surpasses older stool tests in identifying both colorectal cancer and non-cancerous growths called adenomas. It accurately identifies individuals who do not have the disease.

Both colonoscopy and FIT effectively detect colorectal problems, each offering distinct advantages. ^{2 5 6 7 8}

Who Is on the Research Team?

Audrey H Calderwood, MD, MS

Principal Investigator

Dartmouth-Hitchcock Medical Center

Theodore R Levin, MD

Principal Investigator

Kaiser Permante Northern California

Are You a Good Fit for This Trial?

Adults aged 70-82 with a history of one or two non-advanced colorectal polyps and due for surveillance colonoscopy can join. They must speak English or Spanish and be able to consent. Those with serious heart, lung, liver, kidney diseases, dementia affecting daily activities, recent stroke or cancer diagnosis are excluded.

Inclusion Criteria

I have had colorectal polyps in the past.

Most recent colonoscopy with ≤2 non-advanced polyps

Currently due or coming due within 12 months for colonoscopy

Exclusion Criteria

I have a history of inflammatory bowel disease.

Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps

I have had colorectal cancer in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either annual fecal immunochemical testing (FIT) or a one-time surveillance colonoscopy

Up to 6 years

Annual visits for FIT, one-time visit for colonoscopy

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 11 years

What Are the Treatments Tested in This Trial?

Interventions

• Colonoscopy
• FIT

Trial Overview

The trial is comparing yearly stool tests (FIT) versus the standard colonoscopy to monitor older adults who previously had colon polyps. It's a randomized controlled trial across multiple sites where participants are randomly assigned to either method.

How Is the Trial Designed?

Group I: FIT Active Control 1 Intervention

FIT (annual)

Group II: Colonoscopy Active Control 1 Intervention

Surveillance colonoscopy (one time)

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?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

In a study of 1207 subjects who had positive iFOBT results, 46.3% (559 subjects) had negative colonoscopy results, indicating that a positive iFOBT does not always mean colorectal cancer is present.

Factors such as the use of antiplatelet medications, the presence of hemorrhoids, and colitis/ulcers were found to be associated with negative colonoscopy results despite positive iFOBT, suggesting these conditions may lead to false positives in CRC screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The factors associated with negative colonoscopy in screening subjects with positive immunochemical stool occult blood test outcomes. Ting, PH., Lin, XH., Jiang, JK., et al.[2019]

Faecal immunochemical tests (FITs) are more effective than guaiac-based faecal occult blood tests (gFOBT) for colorectal cancer screening, offering better sensitivity and higher participation rates.

Stool-based DNA (sDNA) tests may enhance the detection of colorectal cancer and adenomas compared to gFOBT, but more large-scale studies are needed to confirm their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Performance improvements of stool-based screening tests. van Dam, L., Kuipers, EJ., van Leerdam, ME.[2015]

Fecal immunochemical testing (FIT) is more effective than guaiac-based testing for detecting blood in stools, showing better sensitivity and specificity for colorectal cancer, along with higher patient acceptance.

While FIT is appealing for increasing colorectal screening rates, it primarily detects cancers rather than preventing them by identifying adenomas, which often do not bleed, highlighting the need for caution in implementing new FIT screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining stools for colon cancer prevention: what are we really looking for? Byers, T.[2018]

In a study of 919 asymptomatic patients who underwent total colonoscopy after iFOBT screening, 6.3% of those who tested negative for iFOBT still had advanced colorectal neoplasms, highlighting the test's limitations.

While iFOBT is a useful non-invasive screening tool for colorectal cancer, the findings emphasize the necessity of follow-up colonoscopy to effectively identify and remove potentially harmful lesions that may be missed by the iFOBT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of colorectal tumours in asymptomatic patients with negative immunochemical faecal occult blood test results. Wakamura, K., Kudo, SE., Miyachi, H., et al.[2020]

In a review of 771,730 colonoscopies linked to colorectal cancer screening using FIT or gFOBT, the overall incidence of severe adverse events was found to be low at 0.42%.

Specifically, the risks of serious complications such as perforation, bleeding, and death were minimal, with rates of 0.13%, 0.3%, and 0.01% respectively, indicating that colonoscopy is a safe procedure following positive stool tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonoscopy-Related Adverse Events in Patients With Abnormal Stool-Based Tests: A Systematic Review of Literature and Meta-analysis of Outcomes. Chandan, S., Facciorusso, A., Yarra, P., et al.[2022]

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]

In a study of 7898 patients aged 50-75, replacing the guaiac fecal occult blood test (gFOBT) with the fecal immunochemical test (FIT) significantly increased screening completion rates, with 42.6% of patients completing the FIT compared to 33.4% for the gFOBT.

The FIT also detected advanced neoplasia in a higher proportion of patients (0.79%) compared to the gFOBT (0.28%), suggesting that the FIT is not only more accepted by patients but also more effective in identifying serious conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Replacing the Guaiac Fecal Occult Blood Test With the Fecal Immunochemical Test Increases Proportion of Individuals Screened in a Large Healthcare Setting. Akram, A., Juang, D., Bustamante, R., et al.[2020]

Fecal immunochemical tests (FITs) have largely replaced traditional guaiac-based fecal occult blood tests (gFOBT) for colorectal cancer screening due to their improved sensitivity and specificity, making them a more effective noninvasive option.

Advancements in stool DNA tests have also enhanced their sensitivity for detecting colorectal cancer, positioning them as a promising alternative for screening alongside FITs, as both methods continue to evolve in performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Practical advances in stool screening for colorectal cancer. Potack, J., Itzkowitz, SH.[2019]

Out of 25,219 subjects with a positive Fecal Occult Blood Test (FOBT), 39.6% were non-compliant with colonoscopy, and 0.8% were both non-compliant and had colorectal cancer, highlighting a significant risk for this population.

Machine learning models can effectively reduce the number of subjects needing engagement to identify those at risk, decreasing the number needed to treat (NNT) from 124.8 to as low as 19.4, thus improving the efficiency of cancer detection efforts in non-compliant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of artificial intelligence to identify subjects with a positive FOBT predicted to be non-compliant with both colonoscopy and harbor cancer. Konikoff, T., Flugelman, A., Comanesther, D., et al.[2023]

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]

The immunochemical fecal occult blood test (IFOBT) shows higher sensitivity and specificity for detecting colorectal cancer compared to the conventional Hemoccult test, making it a promising alternative for screening.

Case-control studies suggest that IFOBT could reduce mortality from colorectal cancer by 60% or more, indicating its potential effectiveness in large population screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for colorectal cancer by immunochemical fecal occult blood testing. Saito, H.[2019]

The Auto iFOBT method demonstrated a sensitivity of 60% for detecting colorectal cancer (CRC) at standard cutoff, with higher sensitivities of 90% and 95% for mucosal and submucosal cancers, respectively, indicating its effectiveness in screening for CRC.

With a specificity of 89.6% and a positive predictive value of 86.4% for all neoplasia, the Auto iFOBT is a reliable tool that could support large-scale CRC screening programs, correlating hemoglobin concentrations with cancer severity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A retrospective study of immunochemical fecal occult blood testing for colorectal cancer detection. Oono, Y., Iriguchi, Y., Doi, Y., et al.[2010]

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