Status:
ACTIVE_NOT_RECRUITING
Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
40-69 years
Phase:
PHASE3
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 II...
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 re...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
4952 Patients enrolled
Trial Details
Trial ID
NCT00102011
Start Date
May 1 2000
End Date
May 1 2026
Last Update
June 5 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Feist-Weiller Cancer Center at Louisiana State University Health Sciences
Shreveport, Louisiana, United States, 71130-3932
2
Masonic Cancer Center at University of Minnesota (Data collection only)
Minneapolis, Minnesota, United States, 55455
3
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
4
Kaiser Permanente Washington Health Research Institute (Data collection only)
Seattle, Washington, United States, 98101-1466