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


NCT00906997

Interventional

Phase 3

Active, not recruiting
Aims: 1. 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. 2. 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).
Nov 30,2008
All
50 Years
69 Years
55498

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