Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer (NCT00102011) | Clinical Trial Compass
CompletedPhase 3
Colonoscopy or Fecal Occult Blood Test in Screening Healthy Participants for Colorectal Cancer
United States4,952 participantsStarted 2000-05-25
Plain-language 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.
Who can participate
Age range
40 Years – 69 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy
Timeframe: 5 years
2
Burden on endoscopic and clinical resources
Timeframe: 5 years
3
Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy
Timeframe: 5 years
4
Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy
Timeframe: 5 years
5
Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy