Colonoscopy Screening Trial
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 4,952
- Locations
- 4
- Primary Endpoint
- Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 69 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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:
- •50 to 69 (40 to 69 at the Louisiana State University participating site)
- •Performance status
- •Not specified
- •Life expectancy
- •Not specified
- •Hematopoietic
- •Not specified
- •Not specified
- •Not specified
- •Cardiovascular
- •No myocardial infarction within the past year
- •No congestive heart failure
- •No chronic obstructive pulmonary disease
- •Gastrointestinal
- •No history of ulcerative colitis
- •No history of Crohn's disease
- •No history of inflammatory bowel disease
- •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
- •Not specified
- •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
Exclusion Criteria
- Not provided
Arms & Interventions
Study I- Arm II
Participants receive standard care
Intervention: fecal occult blood test (Procedure)
Study II- Arm I
Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
Intervention: screening colonoscopy (Procedure)
Study II- 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.
Intervention: annual screening (Procedure)
Study II- 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.
Intervention: fecal occult blood test (Procedure)
Study I- Arm I
Participants undergo baseline screening colonoscopy
Intervention: screening colonoscopy (Procedure)
Study I- Arm II
Participants receive standard care
Intervention: standard follow-up care (Procedure)
Outcomes
Primary Outcomes
Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy
Time Frame: 5 years
Burden on endoscopic and clinical resources
Time Frame: 5 years
Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy
Time Frame: 5 years
Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy
Time Frame: 5 years
Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy
Time Frame: 5 years
Secondary Outcomes
No secondary outcomes reported