Overview

This trial is active, not recruiting.

Conditions colorectal cancer, colorectal neoplasm
Treatments immunochemical fecal occult blood test, colonoscopy
Phase phase 3
Sponsor Hospital Clinic of Barcelona
Collaborator Grupo Cooperativo para el Cribado del Cancer Colorrectal en España.
Start date November 2008
End date November 2021
Trial size 55498 participants
Trial identifier NCT00906997, COLONPREV

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose screening
Arm
(Active Comparator)
immunochemical fecal occult blood test
Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
(Active Comparator)
colonoscopy
Every 10 years, with sedation.

Primary Outcomes

Measure
Colorectal cancer-related mortality
time frame: 10 years

Secondary Outcomes

Measure
Compliance rate
time frame: 2 years
Complication rate
time frame: 10 years
Colorectal cancer incidence
time frame: 15 years
Adherence rate
time frame: 10 years
Advanced colorectal neoplasm detection rate
time frame: 2 years

Eligibility Criteria

Male or female participants from 50 years up to 69 years old.

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

Additional Information

Official title Colorectal Cancer Screening in Average-risk Population: a Multicenter, Randomized Control Trial Comparing Immunochemical Fecal Occult Blood Testing Versus Colonoscopy.
Principal investigator Antoni Castells, MD
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Hospital Clinic of Barcelona.