Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.

Hospital Clinic of Barcelona8 sites in 1 country55,498 target enrollmentNovember 2008

Overview

Aims:

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.
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).

Registry

clinicaltrials.gov

Start Date

November 2008

End Date

December 31, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Sponsor

Responsible Party

Principal Investigator

Antoni Castells

Co-principal investigator

Hospital Clinic of Barcelona

•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