Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.

Grupo Cooperativo para el Cribado del Cancer Colorrectal en España., Gastrointestinal Oncology Group of the Spanish Gastroenterological Association, Fundacion Cientifica de la Asociacion Española contra el Cancer, Instituto de Salud Carlos III

Aims: To compare the efficacy of biennial immunochemical fecal occult blood test (iFOBT) versus colonoscopy every 10 years for the reduction of colorectal cancer-related mortality at 10 years in average-risk population. To determine the compliance and complications associated with both strategies. Methods: Multicenter, randomized, controlled study in 8 Spanish regions (Aragón, Canarias, Catalunya, Euskadi, Galicia, Madrid, Murcia and Valencia). Study groups: Group I: iFOBT (OC Sensor®) in one stool sample, followed by colonoscopy when a positive result. Group II: colonoscopy. Sample-size calculation: 27,749 subjects in each study group (total: 55,498).

Colorectal cancer, Screening, Prevention, Fecal occult blood test, Colonoscopy, Colorectal neoplasm, Randomized clinical trial

Inclusion Criteria: Men and women aged 50-69 years Exclusion Criteria: Personal history of colorectal cancer, colorectal adenoma, colorectal polyposis, or inflammatory bowel disease Family history of colorectal polyposis, Lynch syndrome or familial colorectal cancer (2 or more first-degree relatives diagnosed with colorectal cancer or one first-degree relative diagnosed with colorectal cancer before the age of 60) Severe comorbidity Previous total colectomy Not signed informed consent to participate

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