Colonoscopy vs Fecal Occult Blood Test for Colorectal Cancer Screening

(00-046 Trial)

Not currently recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: Anticoagulants, NSAIDs, others

Disqualifiers: Colorectal cancer, Ulcerative colitis, Crohn's, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether colonoscopy or a fecal occult blood test (a simple stool test) is more effective for early detection of colorectal cancer. Participants will undergo either a colonoscopy or the stool test to identify which method detects potential cancer signs sooner. This study targets healthy individuals who have never had colorectal cancer, do not have certain genetic conditions, and have not undergone a colonoscopy in the past. Those who meet these criteria and have been free from colorectal issues might be suitable for the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking cancer detection method.

Do I need to stop taking my current medications for the trial?

The trial does not specify if you need to stop all current medications, but you cannot take nonsteroidal anti-inflammatory drugs (like ibuprofen) within 7 days before and during the fecal occult blood test. You also cannot take anticoagulants or vitamin C over 250 mg within 3 days before and during the test.

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

Research shows that colonoscopy, a common screening method for colorectal cancer, is generally safe. Studies have found that individuals who underwent a colonoscopy had a slightly lower risk of dying from colorectal cancer compared to those who did not, indicating it is a well-tolerated option. However, colonoscopies are invasive, involving the insertion of a camera into the body, which can sometimes cause discomfort or complications.

In contrast, the fecal occult blood test (FOBT) is non-invasive. It checks for hidden blood in stool, a potential sign of colorectal cancer. Research has shown that performing the FOBT annually or biennially can lower the risk of dying from colorectal cancer. Although less invasive than a colonoscopy, participants should have a follow-up colonoscopy if the test detects anything unusual.

Both methods have their pros and cons but are considered safe for colorectal cancer screening. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it aims to compare two widely used screening methods for colorectal cancer: the colonoscopy and the fecal occult blood test (FOBT). The colonoscopy is a more direct approach, allowing doctors to see inside the colon and detect any abnormalities immediately, while the FOBT is less invasive, testing for hidden blood in the stool that may indicate cancer. By comparing these methods, researchers hope to find out which approach is more effective in early detection and ongoing surveillance. This could lead to more personalized screening strategies, improving outcomes and potentially saving more lives through earlier intervention.

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

This trial will compare the effectiveness of colonoscopy and fecal occult blood tests (FOBT) for colorectal cancer screening. Participants in one arm of the trial will undergo a baseline screening colonoscopy. Research indicates that colonoscopy can lower the risk of colorectal cancer by detecting tumors early. One study found that people who had a colonoscopy were less likely to develop colorectal cancer over ten years. In another arm, participants will undergo a baseline fecal occult blood test, with annual follow-ups if the initial test is negative. Regular FOBT can reduce the risk of dying from colorectal cancer by up to 44%. A direct comparison showed that some types of FOBT effectively detect blood in the stool, an early sign of cancer. Both methods are valuable for catching colorectal cancer early and improving health outcomes. ^{1 6 7 8 9}

Who Is on the Research Team?

Ann Zauber, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Healthy individuals aged 50-69 (40-69 at one site), at average risk for colorectal cancer, with no serious health issues or history of certain bowel diseases. Participants should not have had a colonoscopy before and must avoid red meat and certain medications around the time of testing.

Inclusion Criteria

I am healthy and at average risk for colorectal cancer.

I do not have congestive heart failure.

I do not have chronic obstructive pulmonary disease.

Exclusion Criteria

I have had a condition where my lymphocytes grow abnormally.

I have a history of cancer.

I haven't taken any NSAIDs in the last 7 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Screening

Participants undergo baseline screening colonoscopy or fecal occult blood test (FOBT)

1 day

1 visit (in-person)

Annual Follow-up

Participants with negative baseline FOBT undergo FOBT annually for up to 4 years

4 years

Annual visits (in-person)

Follow-up

All participants are followed annually for up to 4 years to monitor outcomes

4 years

What Are the Treatments Tested in This Trial?

Interventions

• annual screening
• fecal occult blood test
• screening colonoscopy
• standard follow-up care

Trial Overview This phase III trial is comparing two types of colorectal cancer screening methods: an annual fecal occult blood test that checks for hidden blood in stool, versus a screening colonoscopy which involves examining the inner lining of the large intestine for abnormalities.

How Is the Trial Designed?

Group I: Study II- Arm I Experimental Treatment 1 Intervention

Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.

Group II: Study I- Arm II Experimental Treatment 2 Interventions

Participants receive standard care

Group III: Study I- Arm I Experimental Treatment 1 Intervention

Participants undergo baseline screening colonoscopy

Group IV: Study II- Arm II Active Control 2 Interventions

Participants undergo a baseline fecal occult blood test (FOBT). Participants are given individualized recommendations for further surveillance based on the results of the FOBT. Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34053963/

Effectiveness of Screening Using Fecal Occult Blood ... The risk of CRC death reduced with increasing the number of FOBTs (P for trend = 0.02) and was reduced by 44% in the subjects screened twice or ...

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2815470

Routine Fecal Occult Blood Screening and Colorectal ... This prospective cohort study of routine screening with fecal occult blood testing found a 14% decrease in CRC mortality associated with screening.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12273078/

Faecal occult blood testing: a review of its use and ... In a head-to-head clinical trial, ColonView FIT outperformed gFOBT in sensitivity (95% vs 76%) while maintaining acceptable specificity (65% vs ...

4. turkishjcrd.com turkishjcrd.com/articles/colonoscopy-findings-in-patients-who-have-positive-fecal-occult-blood-test-for-colorectal-cancer-screening/tjcd.48403

Colonoscopy Findings in Patients Who Have Positive Fecal ... The colonoscopy rate and the rate of detection of malignancy were very low in patients who had positive fecal occult blood test in the present study.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2347562525000186

Effectiveness of health promotion interventions to increase ... A meta-analysis of the 20 included studies demonstrated that health promotion interventions led to significant increases in FOBT uptake rates.

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK537138/

Fecal Occult Blood Test - StatPearls - NCBI Bookshelf The fecal occult blood test (FOBT) is a diagnostic test to assess for hidden (occult) blood in the stool. This test is commonly used for colorectal cancer ...

7. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2779987

Screening for Colorectal Cancer: Updated Evidence ... Annual or biennial guaiac fecal occult blood test (gFOBT) vs no screening (5 trials, n = 419 966) was associated with a reduction of CRC- ...

8. gastrojournal.org gastrojournal.org/article/S0016-5085(24)05302-2/fulltext

Interventions to Increase Follow-Up of Abnormal Stool ... The effectiveness of stool-based CRC screening tests depends on timely follow-up colonoscopy in patients with abnormal results. In landmark randomized ...

9. annalsofoncology.org annalsofoncology.org/article/S0923-7534(19)62781-X/fulltext

Fecal occult blood test for colorectal cancer screening Endoscopic screening is undoubtedly the most effective screening method, but its potential disadvantages, such as invasiveness and cost, should be considered.