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Spots Global Cancer Trial Database for Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

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Trial Identification

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

Study Description

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:

Eligibility

Minimum Age: 50 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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