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

NCT00906997 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55498

Last updated 2025-03-18

No results posted yet for this study

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).

Conditions

Interventions

PROCEDURE

Immunochemical fecal occult blood test

Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.

PROCEDURE

Colonoscopy

Every 10 years, with sedation.

Sponsors & Collaborators

  • Fundacion Cientifica de la Asociacion Española contra el Cancer

    collaborator UNKNOWN

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital Clinic of Barcelona

    lead OTHER

Principal Investigators

  • Antoni Castells, MD · Hospital Clínic, Barcelona, Spain

  • Enrique Quintero, MD · Hospital Universitario de Canarias, Tenerife, Spain

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00906997 on ClinicalTrials.gov