Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
Basic Trial Information
|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 Contact Information
Trial Lead Organizations/Sponsors
Hospital Clinic de Barcelona
- Grupo Cooperativo para el Cribado del Cancer Colorrectal en España.
- Gastrointestinal Oncology Group of the Spanish Gastroenterological Association
- La Fundacion Cientifica de la Asociacion Espanola contra el Cancer
- Instituto De Salud Carlos III
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00906997
ClinicalTrials.gov processed this data on March 31, 2015
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.