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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Colonoscopy Screening Trial

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: annual screening
* Procedure: fecal occult blood test
* Procedure: screening colonoscopy
* Procedure: standard follow-up care


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Healthy participants at average risk for developing colorectal cancer No history of colorectal cancer No history of familial adenomatous polyposis More than 5 years since prior flexible sigmoidoscopy No prior colonoscopy PATIENT CHARACTERISTICS: Age 50 to 69 (40 to 69 at the Louisiana State University participating site) Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic Not specified Renal Not specified Cardiovascular No myocardial infarction within the past year No congestive heart failure Pulmonary No chronic obstructive pulmonary disease Gastrointestinal No history of ulcerative colitis No history of Crohn's disease No history of inflammatory bowel disease Other No serious comorbid condition No consumption of red meat within 3 days prior to and during FOBT (feasibility study II, arm II only) PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No concurrent chemotherapy other than for nonmelanoma skin cancer Endocrine therapy Not specified Radiotherapy Not specified Surgery Not specified Other No vitamin C consumption > 250 mg within 3 days prior to and during fecal occult blood testing (FOBT) (feasibility study II arm II only) No nonsteroidal anti-inflammatory drugs within 7 days prior to and during FOBT (feasibility study II, arm II only) No concurrent anticoagulants No concurrent anticancer therapy except for treatment of nonmelanoma skin cancer

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study I- Arm I<br>Participants undergo baseline screening colonoscopy | Procedure: screening colonoscopy<br>* Patients undergo baseline screening colonoscopy<br>|
| Other: Study I- Arm II<br>Participants receive standard care | Procedure: fecal occult blood test<br>* Participants undergo a baseline fecal occult blood test (FOBT)<br>Procedure: standard follow-up care<br>* Standard care<br>|
| Experimental: Study II- Arm I<br>Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy. | Procedure: screening colonoscopy<br>* Patients undergo baseline screening colonoscopy<br>|
| Active Comparator: Study II- Arm II<br>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. | Procedure: annual screening<br>* Participants with negative baseline FOBT undergo FOBT annually for up to 4 years in the absence of a positive FOBT<br>Procedure: fecal occult blood test<br>* Participants undergo a baseline fecal occult blood test (FOBT)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colon cancer, rectal cancer