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 range40 Years – 69 Years

SexALL

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…

What they're measuring

Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy

Timeframe: 5 years

Burden on endoscopic and clinical resources

Timeframe: 5 years

Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy

Timeframe: 5 years

Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy

Timeframe: 5 years

Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy

Timeframe: 5 years

Trial details

NCT IDNCT00102011

SponsorMemorial Sloan Kettering Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-03-05

View on ClinicalTrials.gov More Colorectal Cancer trials

Plain-language summary

Who can participate

Age range40 Years – 69 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Neoplastic findings as assessed by screening colonoscopy vs annual fecal occult blood test (FOBT)-directed colonoscopy

Timeframe: 5 years

Burden on endoscopic and clinical resources

Timeframe: 5 years

Harms associated with screening colonoscopy vs annual FOBT-directed colonoscopy

Timeframe: 5 years

Benefit-to-harm ration for screening colonoscopy vs annual FOBT-directed colonoscopy

Timeframe: 5 years

Level of participation in screening with FOBT-directed colonoscopy vs a single colonoscopy

Timeframe: 5 years