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Colonoscopy vs Fecal Occult Blood Test for Colorectal Cancer Screening (00-046 Trial)

Phase 3

Waitlist Available

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No congestive heart failure

No chronic obstructive pulmonary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

00-046 Trial Summary

This trial is comparing colonoscopy to the fecal occult blood test in screening for colorectal cancer in healthy people.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Colonoscopy may cause discomfort, bloating, cramping or rarely more serious complications like bleeding or tears in the colon wall. The fecal occult blood test is non-invasive but dietary restrictions are required to avoid false results.

00-046 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have congestive heart failure.

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I do not have chronic obstructive pulmonary disease.

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I have not had a heart attack in the last year.

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I have never had ulcerative colitis.

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I have never had Crohn's disease.

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I am between 50 and 69 years old.

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I have never had inflammatory bowel disease.

00-046 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy

Burden on endoscopic and clinical resources

Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy

+2 more

00-046 Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Study II- Arm IExperimental Treatment1 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 IIExperimental Treatment2 Interventions

Participants receive standard care

Group III: Study I- Arm IExperimental Treatment1 Intervention

Participants undergo baseline screening colonoscopy

Group IV: Study II- Arm IIActive Control2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

standard follow-up care

2007

Completed Phase 3

~1390

screening colonoscopy

2013

N/A

~1420

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

580,668 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,928,201 Total Patients Enrolled

Ann Zauber, PhDStudy ChairMemorial Sloan Kettering Cancer Center

Media Library

Colorectal Cancer Clinical Trial 2023: fecal occult blood test Highlights & Side Effects. Trial Name: NCT00102011 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people aged 40 or older able to participate in this clinical trial?

"According to the rules governing who can participate in this clinical trial, the minimum age is 40 and the maximum age is 69."

Answered by AI

Could I possibly be included as a subject in this experiment?

"Colorectal cancer patients that are 40 to 69 years old are qualified to participate in this study. Up to 4952 total people are able to join the clinical trial."

Answered by AI

Are there different testing facilities for this study within the US?

"There are 6 sites conducting this trial, 3 of which are in Seattle, Shreveport and New york. The other 6 locations for this study have not been specified. It would be convenient for you to select a clinic near to your home to reduce travel commitment."

Answered by AI