Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
|ClinicalTrials.gov Identifier: NCT00906997|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2009
Last Update Posted : April 1, 2015
- 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.
- 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).
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Colorectal Neoplasm||Procedure: Immunochemical fecal occult blood test Procedure: Colonoscopy||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55498 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
|Active Comparator: Fecal occult blood testing||
Procedure: Immunochemical fecal occult blood test
Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
|Active Comparator: Colonoscopy||
Every 10 years, with sedation.
- Colorectal cancer-related mortality [ Time Frame: 10 years ]
- Compliance rate [ Time Frame: 2 years ]
- Complication rate [ Time Frame: 10 years ]
- Colorectal cancer incidence [ Time Frame: 15 years ]
- Adherence rate [ Time Frame: 10 years ]
- Advanced colorectal neoplasm detection rate [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906997
|Hospital del Mar|
|Hospital Universitario Virgen de la Arrixaca|
|Hospital de Donosti|
|San Sebastián, Spain|
|Hospital Universitario de Canarias|
|Hospital Clínico Lozano Blesa|
|Principal Investigator:||Antoni Castells, MD||Hospital Clínic, Barcelona, Spain|
|Principal Investigator:||Enrique Quintero, MD||Hospital Universitario de Canarias, Tenerife, Spain|