Colon Polyp Surveillance with DNA Analysis of Stool

University Of Michigan At Ann Arbor, Ann Arbor MI

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Abstract

DESCRIPTION: Clinical practice guidelines state that individuals with a history of colon adenomas should undergo surveillance colonoscopy to identify and remove newly formed colon adenomas. Cost-effectiveness studies suggest that the cost of repeated surveillance colonoscopies drives the cost of colorectal cancer prevention, and surveillance colonoscopy is also associated with significant endoscopic complications. Therefore, it is preferable to develop accurate, non-invasive, and more economical surveillance tests. Multi-target DNA-based assay panels (MTAP) of stool may accurately diagnose colon adenomas. Small preliminary studies (n=39) demonstrate that fecal MTAP accurately diagnoses colon adenomas> 10 mm in diameter (sensitivity = 82 percent (95 percent Cl: 48 percent-98 percent); specificity = 93 percent (95 percent Cl: 76 percent-99 percent)). If this non-invasive test truly mimics the accuracy of the gold-standard test, surveillance colonoscopy, then fecal MTAP may offer a safer and more economical approach to colon adenoma surveillance. However, no studies about the diagnostic accuracy of fecal MTAP have been performed among patients with a personal history of colon adenomas. It is also important to assess patient satisfaction and anxiety associated with fecal MTAP vs. colonoscopy since this test must also be acceptable to patients in order to be effective. Therefore, we propose an observational study about the diagnostic accuracy of fecal MTAP for colon adenomas among 405 patients with a personal history of colon adenomas. Surveillance colonoscopy will be used as the gold standard diagnostic test for identification of colon adenomas. Results of surveillance colonoscopy will be compared to results of fecal MTAP to determine the diagnostic accuracy of fecal MTAP for colon adenomas. Patient satisfaction and anxiety for colonoscopy vs. fecal MTAP as a surveillance tool will also be assessed. The three Specific Aims of this trial are to: 1) Measure the diagnostic accuracy (i.e., sensitivity, specificity, positive and negative predictive values) of fecal MTAP for colon adenomas (any size) among a cohort of individuals with a personal history of colon adenomas; 2) Quantify the diagnostic accuracy of fecal MTAP for colorectal cancers and advanced adenomas (adenoma> 10 mm in diameter, villous adenoma, or adenoma with high-grade dysplasia) among a cohort of patients with a personal history of colon adenomas; 3) Use appropriate questionnaires to assess patient satisfaction and anxiety for fecal MTAP vs. colonoscopy as a surveillance tool. Ultimately, this trial will produce pilot data to determine if a randomized controlled trial of fecal MTAP vs. colonoscopy for colon adenoma surveillance should be performed.