Colon Polyp Surveillance with DNA Analysis of Stool

描述：临床实践指南指出，有病史的个人 的结肠腺瘤应进行监测结肠镜检查，以确定和 切除新形成的结肠腺瘤。成本效益研究表明， 重复监测结肠镜检查的费用推动了结肠直肠的费用 癌症预防和结肠镜检查监测也与 严重的内镜并发症。因此，最好开发 准确、非侵入性和更经济的监测测试。多目标 粪便的基于DNA的检测板（MTAP）可以准确地诊断结肠腺瘤。 小型初步研究（n=39）表明，粪便MTAP准确 诊断直径> 10 mm的结肠腺瘤（敏感性= 82%（95 % CI：48%-98%）;特异性= 93%（95% CI：76 %-99%））。如果这种非侵入性的测试真的模仿了 金标准测试，监测结肠镜检查，然后粪便MTAP可以提供一个 更安全、更经济的结肠腺瘤监测方法。但没有 关于粪便MTAP诊断准确性的研究已经在 有结肠腺瘤病史的患者。也很重要 评估患者满意度和焦虑与粪便MTAP与 结肠镜检查，因为该测试也必须是患者可接受的， 有效因此，我们提出了一项关于诊断的观察性研究， 405例结肠腺瘤患者粪便MTAP的准确性 结肠腺瘤病史。监测结肠镜检查将被用作黄金 用于识别结肠腺瘤的标准诊断测试。结果 监测结肠镜检查将与粪便MTAP结果进行比较，以确定 粪便MTAP诊断结肠腺瘤的准确性。患者满意度 结肠镜检查与粪便MTAP作为监测工具的焦虑也将 评估。本试验的三个具体目标是：1）测量 诊断准确性（即，灵敏度、特异性、阳性和阴性 粪便MTAP对结肠腺瘤（任何大小）的预测值 有结肠腺瘤个人病史的个体; 2）量化 粪便MTAP对结直肠癌和晚期腺瘤的诊断准确性 （腺瘤直径> 10 mm，绒毛状腺瘤，或腺瘤伴高级别 在有结肠癌个人病史的患者队列中， 3）使用适当的问卷来评估患者的满意度， 粪便MTAP与结肠镜检查作为监测工具的焦虑。最终这 试验将产生初步数据，以确定是否进行随机对照试验， 应进行粪便MTAP与结肠镜检查以监测结肠腺瘤。

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.