Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy
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|ClinicalTrials.gov Identifier: NCT00906997|
Recruitment Status : Unknown
Verified March 2015 by Antoni Castells, Hospital Clinic of Barcelona.
Recruitment status was: Active, not recruiting
First Posted : May 21, 2009
Last Update Posted : April 1, 2015
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- 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 ]
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|Ages Eligible for Study:||50 Years to 69 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Antoni Castells, Co-principal investigator, Hospital Clinic of Barcelona|
|Other Study ID Numbers:||
|First Posted:||May 21, 2009 Key Record Dates|
|Last Update Posted:||April 1, 2015|
|Last Verified:||March 2015|
Fecal occult blood test
Randomized clinical trial
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases