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

Hospital Clinic of Barcelona

Status: Completed

Conditions: Colorectal Neoplasm; Colorectal Cancer

Treatments: Procedure: Immunochemical fecal occult blood test; Procedure: Colonoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT00906997

COLONPREV

Details and patient eligibility

About

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).

Enrollment: 55,498 patients

Sex: All

Ages: 50 to 69 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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55,498 participants in 2 patient groups

Fecal occult blood testing

Active Comparator group

Description:

Fecal immunochemical testing biennially

Treatment:

Procedure: Immunochemical fecal occult blood test

Colonoscopy

Active Comparator group

Description:

Colonoscopy one time

Treatment:

Procedure: Colonoscopy