Abstract
Numerous studies have shown that early screening for the presence of pre-cancerous colon polyps and their subsequent removal decreases the risk of developing colon cancer. Colonoscopy is currently the most effective screening method, but due to the invasive nature of the procedure many patients avoid forgo testing. Futhermore, the procedure itself requires perfect execution by the gastroenterologist. Against this backdrop, a non-invasive blood screening method for the detection of colon polyps that has higher sensitivity than current screening techniques would be beneficial in the early identification of patients at risk for colon cancer. A prospective, double-blinded, controlled clinical study was designed to demonstrate the diagnostic performance of Polyp Specific Polymer analysis, a novel laboratory methodology. The primary objective of this clinical trial was to estimate the diagnostic accuracy of the Polyp Specific Polymer analysis for colon polyps using colonoscopy and histological tests as the diagnostic accuracy standards. Secondary objectives of this trial included estimating positive and negative predictive values for colon polyps, investigating reliability, determining covariates influencing diagnostic accuracy and obtaining absolute and relative frequencies of valid test results.In patients undergoing screening colonoscopy and histology examination, a sensitivity of 72.4% and a specificity of 62.3% could be proven.These results indicate that using this improved screening method it is possible to effectively identify the highest-risk candidates for endoscopy, thereby advancing the goal of decreasing the incidence or mortality of colorectal cancer in the selected population. Moreover, this diagnostic tool has potential socio-economic implications, conserving healthcare resources by enabling higher patient selectivity for endoscopy and eventual transfer to curative prevention via polypectomy.By combining the best-established low-risk screening elements together with a validated, highly sensitive blood test as described in this study, a steadfast increase in the estimation of colorectal cancer-risk before colonoscopy can be expected.