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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SCREENING
Masking
NONE
Enrollment
55,498
Biennial, without diet restriction, 1 stool sample. Positive cut-off level: 75 ng/ml.
Every 10 years, with sedation.
Hospital del Mar
Barcelona, Spain
Hospital Clínico
Madrid, Spain
Hospital Universitario Virgen de la Arrixaca
Murcia, Spain
Hospital Meixoeiro
Ourense, Spain
Hospital de Donosti
San Sebastián, Spain
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Spain
Comunidad Valencia
Valencia, Spain
Hospital Clínico Lozano Blesa
Zaragoza, Spain
Colorectal cancer-related mortality
Time frame: 10 years
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.