Screening for colorectal cancer: A blinded multicenter phase II diagnostic study for validation of a DNA based stool test (GeneFec2©)

Aims: Endoscopy-based screening has been adopted as gold standard for colorectal cancer (CRC) screening in most western countries, although patient acceptance has been disappointing. Screening tests using stool samples would be easy to perform with no risks to the patients, but so far detection rates remain unsatisfactory. Aim: To evaluate validity and feasibility of a DNA based stool screening test (GeneFec2©) in comparison with commercially available tests (faecal occult blood test (FOBT) or tumor M2 pyruvate kinase (M2-PKTM)) for detection of CRC. Methods: Between August 2005 and May 2007 734 patients were re…