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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

Must not have

History of any lymphoproliferative disorder

History of active malignancy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a condition where my lymphocytes grow abnormally.

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I have a history of cancer.

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I am not receiving any cancer treatment except for nonmelanoma skin cancer.

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I have a family history of multiple colon polyps.

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I have a history of colorectal cancer.

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I am not taking any blood thinners.

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I am not receiving chemotherapy, except for treating nonmelanoma skin cancer.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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