Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer

Phase 3

Active, not recruiting

• Conditions: Colorectal Cancer
• Interventions: Procedure: fecal occult blood test; Procedure: screening colonoscopy; Procedure: annual screening; Procedure: standard follow-up care

• Registration Number: NCT00102011
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

OBJECTIVES:

* Compare the neoplastic outcome of participants at average risk for colorectal cancer who undergo colonoscopy vs annual fecal occult blood tests.

* Compare the endoscopic and clinical resources required for these screening methods in these participants.

* Compare the benefit-to-harm ratio in participants undergoing these screening methods.

* Determine the level of participation of participants undergoing these screening methods.

OUTLINE: This is a randomized, two-part, multicenter study.

Participants are asked whether they are interested in participating in a randomized controlled trial of colorectal cancer screening.

* Screening colonoscopy feasibility study I (accrual completed as of 12/14/2004): Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.

* Arm I: Participants undergo baseline screening colonoscopy.

* Arm II: Participants receive standard care.

* Screening colonoscopy feasibility study II: Participants who are interested in participating in a screening trial are randomized to 1 of 2 screening arms.

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

* Arm II: 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.

All participants are followed annually for up to 4 years.

PROJECTED ACCRUAL: A total of 1,402 participants (701 per screening arm) have been accrued for feasibility study I within 3 years (accrual completed as of 12/14/2004). An additional 3,550 participants (1,775 per screening arm) will be accrued for feasibility study II within 5 years.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2000-05
• Study First Submitted: 2005-01-18
• Study First Submitted QC: 2005-01-18
• Study First Posted: 2005-01-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-05
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4952

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study I- Arm II	fecal occult blood test	Participants receive standard care
Study I- Arm I	screening colonoscopy	Participants undergo baseline screening colonoscopy
Study II- Arm I	screening colonoscopy	Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
Study I- Arm II	standard follow-up care	Participants receive standard care
Study II- Arm II	annual screening	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.
Study II- Arm II	fecal occult blood test	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.

Primary Outcome Measures

Name	Time	Method
Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy	5 years
Burden on endoscopic and clinical resources	5 years
Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy	5 years
Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy	5 years
Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy	5 years

Trial Locations

Locations (4)

Masonic Cancer Center at University of Minnesota (Data collection only); 🇺🇸 Minneapolis, Minnesota, United States

Kaiser Permanente Washington Health Research Institute (Data collection only); 🇺🇸 Seattle, Washington, United States

Feist-Weiller Cancer Center at Louisiana State University Health Sciences; 🇺🇸 Shreveport, Louisiana, United States

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States