Comparison of Performances of Two Automated Immunochemical Faecal Occult Blood Tests in Colorectal Cancer Screening, in Reference to Usual Care Guaiac Test
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Screening
Ratio of sensitivities (RSN) for detection of advanced neoplasias
Advanced neoplasias included invasive cancers and high-risk adenomas (larger than 1 cm or with high grade dysplasia). RSN is the ratio of the true positives of two tests. True positives for one test are patients positive for the test, with targeted lesion (here advanced neoplasias). RSN will be calculed between immunochemical tests, and for each immunochemical test in reference to gaiac test.
Up to 6 months after faecal occult blood test (FOBT) (At the time of colonoscopy)
Guy LAUNOY, MD-PhD
University Hospital, Caen
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)