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

Not Applicable

Completed

• Conditions: Colorectal Cancer; Colorectal Neoplasm
• Interventions: Procedure: Colonoscopy; Procedure: Immunochemical fecal occult blood test

• Registration Number: NCT00906997
• Lead Sponsor: Hospital Clinic of Barcelona

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2009-05-19
• Study First Submitted QC: 2009-05-19
• Study First Posted: 2009-05-21
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55498

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colonoscopy	Colonoscopy	-
Fecal occult blood testing	Immunochemical fecal occult blood test	-

Primary Outcome Measures

Name	Time	Method
Colorectal cancer-related mortality	10 years

Secondary Outcome Measures

Name	Time	Method
Advanced colorectal neoplasm detection rate	2 years
Compliance rate	2 years
Complication rate	10 years
Colorectal cancer incidence	15 years
Adherence rate	10 years

Trial Locations

Locations (8)

Hospital Universitario de Canarias; 🇪🇸 Tenerife, Spain

Hospital Clínico; 🇪🇸 Madrid, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Universitario Virgen de la Arrixaca; 🇪🇸 Murcia, Spain

Hospital Meixoeiro; 🇪🇸 Ourense, Spain

Comunidad Valencia; 🇪🇸 Valencia, Spain

Hospital Clínico Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital de Donosti; 🇪🇸 San Sebastián, Spain