Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer (00-046)
Colorectal Cancer
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring colon cancer, rectal cancer
Eligibility 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: 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
Sites / Locations
- Feist-Weiller Cancer Center at Louisiana State University Health Sciences
- Masonic Cancer Center at University of Minnesota (Data collection only)
- Memorial Sloan-Kettering Cancer Center
- Kaiser Permanente Washington Health Research Institute (Data collection only)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Other
Experimental
Active Comparator
Study I- Arm I
Study I- Arm II
Study II- Arm I
Study II- Arm II
Participants undergo baseline screening colonoscopy
Participants receive standard care
Participants undergo baseline screening colonoscopy. Participants are given individualized recommendations for further surveillance based on the results of the colonoscopy.
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.