Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

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

Antoni Castells, MD

Principal Investigator

Enrique Quintero, MD

Principal Investigator

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

Back to Top