|Phase III||Screening||Closed||50 to 69||Other||COLONPREV|
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).
- 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).
- Men and women aged 50-69 years
- 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
Trial Lead Organizations/Sponsors
Hospital Clinic de BarcelonaGrupo 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
|Antoni Castells, MD||Principal Investigator|
|Enrique Quintero, MD||Principal Investigator|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00906997
Information obtained from ClinicalTrials.gov on November 20, 2012
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