Evaluation of novel serological markers for early diagnosis of colorectal neoplasia SID 85

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With approximately 70,000 new cases per year, colorectal cancer (CRC) is the most common cancer in Germany. Most of the almost 30,000 CRC deaths per year could, in theory, be prevented by early detection and removal of adenomas and early cancer stages via colonoscopy which is offered as primary screening examination in Germany since October 2007. However, due to its invasiveness and discomfort, participation rates in screening colonoscopy remain low, and complementary, less invasive approaches to early detection are needed. Existing alternatives, such as fecal occult blood testing,suffer from poor sensitivity, especially with respect to adenomas. Recently, several colon cancer-specific markers, denoted colon cancer specific antigen (CCSA)-2, -3, and -4, have been identified and reported to have promising sensitivity and specificity in preliminary small-scale studies mostly conducted in clinical settings. In this multi-center project, performance of the three markers (individually and in combination) for early detection of CRC and advanced adenomas will be evaluated among 2,000 participants of the German colonoscopy screening program. Using findings at colonoscopy as gold standard, sensitivity and specificity will be determined at predefined cutpoints. Key secondary endpoints include positive and negative predictive values, ROC curves, likelihood ratios and numbers needed to screen.