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Brief Title: Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Official Title: Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
Study ID: NCT00906997
Brief Summary: 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).
Detailed Description:
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital del Mar, Barcelona, , Spain
Hospital Clínico, Madrid, , Spain
Hospital Universitario Virgen de la Arrixaca, Murcia, , Spain
Hospital Meixoeiro, Ourense, , Spain
Hospital de Donosti, San Sebastián, , Spain
Hospital Universitario de Canarias, Tenerife, , Spain
Comunidad Valencia, Valencia, , Spain
Hospital Clínico Lozano Blesa, Zaragoza, , Spain
Name: Antoni Castells, MD
Affiliation: Hospital Clínic, Barcelona, Spain
Role: PRINCIPAL_INVESTIGATOR
Name: Enrique Quintero, MD
Affiliation: Hospital Universitario de Canarias, Tenerife, Spain
Role: PRINCIPAL_INVESTIGATOR