Comparative Effectiveness of Fecal Immunochemical Tests with Optical Colonoscopy

项目总结/摘要 结直肠癌（CRC）是第三大最常见的癌症，也是癌症死亡的第三大原因， 美国的男人和女人，每年有近五万人死亡由于CRC是在多个 从称为息肉的前驱病变开始，在早期阶段，它在很大程度上是可以检测和预防的。因为这些 息肉变得更大，他们，像大多数CRC一样，倾向于出血，这是使用粪便隐匿的基本原理 血液测试（FOBTs）可以在息肉和癌症可以治愈的时候早期发现它们。然而，早 筛查和检测远没有想象中那么普遍，大约43%的合格个体 未经筛选。粪便免疫化学试验（FIT）是一种FOBT，可以是一种敏感，特异性和低- CRC筛查的结肠镜检查的成本替代方案。模拟研究表明，对于人群筛查， 从50岁到75岁每年进行一次FIT测试的策略， 与每十年一次的结肠镜检查相比。然而，在美国，大约90%的筛查是在 结肠镜检查，最昂贵和侵入性的筛查测试。FIT的成本要低得多，而且在很大程度上取代了 国际上CRC筛查项目中的愈创木脂试验，仅涉及阳性结果的个体 做结肠镜检查在其他国家进行的关于FIT的研究通常使用美国没有的FIT， 高风险人群;因此，结果不适用于美国。 最好的测试特性，以便在这个国家实施成功的基于FIT的筛查计划。 据估计，到2018年，需要筛查的人数将增加2400万，以达到“80%， 2018年“全国结直肠癌圆桌会议”设定的目标。为了解决这一知识差距，我们建议 使用结肠镜检查比较三种CLIA豁免FIT和两种自动FIT的测试特征 作为黄金标准。这项拟议研究的理由是，对于目前市售的几乎所有FIT， 在美国，没有证据证明所声称的准确性。我们的目标是： 目的1：评估三种最常见的晚期结直肠肿瘤的诊断准确性 常用的CLIA豁免FIT和两种自动FIT，使用结肠镜检查作为金标准。 目的2：利用受试者工作特性评价两种定量FIT的诊断准确性 (ROC)分析. 目的3：评估与每种器械的假阳性和假阴性FIT结果相关的因素。 这些发现将为未来的FIT提供最佳测试特性的基本信息 扩大使用FIT，这对实现我们降低发病率和死亡率的长期目标至关重要 从CRC。FIT更容易被患者接受，将允许更高的筛查率，并将降低成本， 与基于结肠镜检查作为主要初始筛查方法的筛查策略相比。

Project Summary/Abstract Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer death in both men and women in the U.S., with nearly 50,000 deaths each year. Since CRC develops over a number of years from precursor lesions called polyps, it is largely detectable and preventable in early stages. As these polyps become larger, they, like most CRCs, tend to bleed, which is the rationale for the use of fecal occult blood tests (FOBTs) to detect both polyps and cancers early, while they are curable. However, early screening and detection is much less common than it could be, with about 43% of eligible individuals unscreened. Fecal immunochemical tests (FITs) are a type of FOBT that can be a sensitive, specific, and low- cost alternative to colonoscopy for CRC screening. Modeling studies have shown that for population screening, a strategy of annual FIT testing from age of 50 to 75 years results in an equal number of life-years gained as compared with colonoscopy every 10 years. However, about 90% of screening in the U.S. is done with colonoscopy, the most expensive and invasive screening test. FITs are far less costly and largely replacing the guaiac test in CRC screening programs internationally, where only individuals with positive results are referred for a colonoscopy. Studies done on FITs in other countries often used FITs not available in the U.S. or studied high-risk populations; thus, results are not applicable in the U.S. It is critical to determine the FIT(s) with the best test characteristics in order to implement successful FIT-based screening programs in this country. It is estimated that 24 million more individuals will need to be screened by 2018 to reach the “80% by 2018” goal set by the National Colorectal Cancer Roundtable. To address this knowledge gap, we propose to compare the test characteristics of three CLIA-waived FITs and two automated FITs, using colonoscopy as the gold standard. The rationale for this proposed study is that, for almost all of the FITs currently marketed in the U.S., there is no evidence of the accuracy claimed. Our aims are: Aim 1: To assess the diagnostic accuracy for advanced colorectal neoplasms of three of the most commonly used CLIA-waived FITs and two automated FITs, using colonoscopy as the gold standard. Aim 2: To evaluate the diagnostic accuracy of two quantitative FITs using receiver operating characteristic (ROC) analysis. Aim 3: To assess factors associated with false positive and false negative FIT results for each device. These findings will provide essential information about FITs with the best test characteristics for future expanded use of FIT, critically important to achieving our long-term goal of reducing morbidity and mortality from CRC. FITs are more acceptable to patients, will allow higher screening rates, and will reduce costs as compared with a screening strategy based on colonoscopy as the primary initial screening method.