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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIScreeningClosed50 to 69OtherCOLONPREV
NCT00906997

Trial Description

Summary

Aims:

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

Fundacion Cientifica de la Asociacion Española contra el Cancer

Instituto De Salud Carlos III

Antoni Castells, MDPrincipal Investigator

Enrique Quintero, MDPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00906997
Information obtained from ClinicalTrials.gov on November 20, 2012

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.