Colonoscopy vs Fecal Occult Blood Test for Colorectal Cancer Screening

(00-046 Trial)

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

4952 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: Screening tests, such as colonoscopy and fecal occult blood test, may help doctors find tumor cells early and plan better treatment for colorectal cancer. PURPOSE: This randomized phase III trial is studying colonoscopy to see how well it works compared to fecal occult blood test in screening healthy participants for colorectal cancer.

Research Team

Ann Zauber, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+