Colonoscopy vs Stool Testing for Colorectal Polyps

(COOP Trial)

Recruiting at 13 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

Trial Summary

What is the purpose of this trial?

This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

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.

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

Research shows that colonoscopy is highly accurate for detecting colorectal lesions, and the fecal immunochemical test (FIT) is effective in reducing mortality from colorectal cancer due to its improved sensitivity and specificity compared to older tests. Screening with FIT has been associated with a significant reduction in mortality from colorectal cancer. ^{1 2 3 4 5}

Is colonoscopy safe for humans?

Colonoscopy is generally safe, but it can have some risks like bleeding or perforation (a small tear) in the colon. A review of studies found that these adverse events are rare, especially when colonoscopy is done after a positive stool test. ^{2 5 6 7 8}

How does the treatment of colonoscopy and FIT differ from other treatments for colorectal polyps?

Colonoscopy is a direct visual examination of the colon, allowing for the detection and removal of polyps, while the Fecal Immunochemical Test (FIT) is a non-invasive stool test that detects hidden blood, which can indicate the presence of polyps or cancer. FIT is more sensitive and patient-friendly compared to older stool tests, but colonoscopy is more effective for prevention as it can remove polyps before they turn into cancer. ^{5 9 10 11 12}

Research Team

Audrey H Calderwood, MD, MS

Principal Investigator

Dartmouth-Hitchcock Medical Center

Theodore R Levin, MD

Principal Investigator

Kaiser Permante Northern California

Eligibility Criteria

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 speak English or Spanish.

I have had colorectal polyps in the past.

Most recent colonoscopy with ≤2 non-advanced polyps

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

References

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

Practical advances in stool screening for colorectal cancer. [2019]

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

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

3. Japan pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

A retrospective study of immunochemical fecal occult blood testing for colorectal cancer detection. [2010]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The factors associated with negative colonoscopy in screening subjects with positive immunochemical stool occult blood test outcomes. [2019]

6. United States 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. [2022]

7. Netherlands 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Characteristics of colorectal tumours in asymptomatic patients with negative immunochemical faecal occult blood test results. [2020]

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]

10. United States 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. [2020]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Performance improvements of stool-based screening tests. [2015]

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

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