Colon Polyp Surveillance with DNA Analysis of Stool

通过粪便 DNA 分析进行结肠息肉监测

• 批准号: 6421802
• 负责人: PHILIP S SCHOENFELD
• 金额: $ 15.49万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-24 至 2004-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6421802
• 关键词: adenomatous polyps; clinical research; colon polyp; diagnosis design /evaluation; diagnosis quality /standard; feces analysis; human subject; neoplasm /cancer diagnosis; noninvasive diagnosis; patient oriented research; psychological aspect of cancer; questionnaires

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.

描述：临床实践指南规定，有病史的个人 结肠腺瘤应接受监视结肠镜检查，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成本推动了结直肠手术的成本 癌症预防和监测结肠镜检查也与 严重的内窥镜并发症。因此，最好是发展 准确、非侵入性和更经济的监控测试。多目标 粪便DNA分析板(MTAP)可准确诊断结肠腺瘤。 小规模初步研究(n=39)证明粪便MTAP准确 诊断直径10 mm的结肠腺瘤(敏感度=82%(95 氯离子百分比：48%-98%)；特异性=93%(95%氯离子：76 %-99%))。如果这种非侵入性测试真的模仿了 黄金标准检测，监督结肠镜检查，然后粪便MTAP可能会提供 更安全、更经济的结肠腺瘤监测方法。然而，没有 关于粪便MTAP诊断准确性的研究已经在以下几个方面进行 有结肠腺瘤个人病史的患者。同样重要的是， 评估与粪便MTAP相关的患者满意度和焦虑 结肠镜检查，因为这项检查也必须被患者接受，才能 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检测的准确性 结肠腺瘤病史。监视结肠镜检查将被用作黄金 识别结肠腺瘤的标准诊断试验。结果： 将监测结肠镜检查结果与粪便MTAP结果进行比较，以确定 粪便MTAP对结肠腺瘤诊断的准确性。患者满意度 而将结肠镜检查与粪便MTAP作为监测工具的焦虑也将 评估过了。这项试验的三个具体目标是：1)测量 诊断准确性(即敏感性、特异性、阳性和阴性 粪便MTAP在队列中对结肠腺瘤(任何大小)的预测价值 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诊断的准确性 (腺瘤直径10 mm，绒毛状腺瘤，或高级别腺瘤 在一组有结肠史的患者中) 腺瘤；3)使用适当的问卷来评估患者的满意度和 对粪便MTAP的焦虑与结肠镜检查作为监测工具的对比。归根结底，这 试验将产生试验数据，以确定一项随机对照试验 对于结肠腺瘤的监测，应进行粪便MTAP与结肠镜检查。