Colorectal Cancer Screening in Average-risk Population: Immunochemical Fecal Occult Blood Testing Versus Colonoscopy

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIScreeningClosed50 to 69OtherCOLONPREV

Trial Description



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).

Eligibility Criteria

Inclusion Criteria:

  • Men and women aged 50-69 years

Exclusion Criteria:

  • 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
Antoni Castells, MD, Principal Investigator
Enrique Quintero, MD, Principal Investigator

Link to the current record.
NLM Identifier NCT00906997 processed this data on March 31, 2015

Note: Information about this trial is from the database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the record to standardize the names of study sponsors, sites, and contacts. only lists sites that are recruiting patients for active trials, whereas lists all sites for all trials. Questions and comments regarding the presented information should be directed to