Comparative Effectiveness of Fecal Immunochemical Tests with Optical Colonoscopy

粪便免疫化学测试与光学结肠镜检查的效果比较

• 批准号: 10196985
• 负责人: BARCEY Thurston LEVY
• 金额: $ 62.31万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10196985
• 关键词: Address; Age; Amendment; CCL4 gene; Cancer Etiology; Cessation of life; Characteristics; Clinical; Colonoscopy; Colorectal Cancer; Colorectal Neoplasms; Country; Data; Developed Countries; Devices; Early Diagnosis; Fecal occult blood; Foundations; Future; Goals; Gold; Guaiac; Home; Individual; International; Knowledge; Laboratories; Lesion; Life; Malignant Neoplasms; Manufacturer Name; Medical Care Costs; Methods; Modality; Modeling; Morbidity - disease rate; Neoplasms; Optics; Pathology; Patients; Pharmaceutical Preparations; Physicians' Offices; Polyps; Population; Privacy; ROC Curve; Reading; Risk; Safety; Sampling; Specific qualifier value; Study models; Test Result; Testing; United States; United States Food and Drug Administration; Woman; Work; adenoma; base; colorectal cancer screening; comparative effectiveness; cost; cost estimate; diagnostic accuracy; dietary; early screening; high risk population; men; mortality; population based; screening; screening guidelines; screening program

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.

项目摘要/摘要 结直肠癌(CRC)是第三大常见癌症，也是导致两种癌症死亡的第三大原因。 美国的男性和女性，每年有近5万人死亡。由于CRC的发展超过了许多 在被称为息肉的前驱病变多年后，它在很大程度上是可以检测到的，并可以在早期阶段预防。就像这些 息肉变得更大，它们像大多数癌一样，倾向于出血，这是使用粪便隐匿法的基本原理 血液检测(FOBT)可以在息肉和癌症可以治愈的情况下及早发现它们。然而，早些时候 筛查和检测比实际情况要少得多，大约有43%的合格个人 未经筛选。粪便免疫化学试验(FITS)是一种敏感、特异和低水平的FOBT。 结直肠癌筛查的成本替代结肠镜检查。建模研究表明，对于人口筛查， 从50岁到75岁进行年度适合度测试的策略会导致相同数量的寿命增长 与每10年一次的结肠镜检查相比。然而，在美国，大约90%的筛查是通过 结肠镜检查是最昂贵和最具侵入性的筛查检查。Fits的成本要低得多，而且在很大程度上取代了 国际上结直肠癌筛查项目中的愈创木酚检测，只有阳性结果的人才会被转介 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或研究过的Fit 高危人群；因此，结果不适用于美国。关键是确定(S)与 最好的测试特征，以便在该国成功实施基于适合度的筛查计划。 据估计，到2018年，还需要对2400万人进行筛查，才能在 2018年由全国结直肠癌圆桌会议设定的目标。为了解决这一知识鸿沟，我们建议 使用结肠镜检查比较三种CLIA-放弃配对和两种自动配对的测试特征 作为黄金标准。这项拟议研究的基本原理是，对于目前市场上销售的几乎所有Fit 在美国，没有证据表明这一说法是准确的。我们的目标是： 目的1：评价进展期结直肠癌诊断的准确性。 常用的CLIA-放弃配合和两个自动配合，使用结肠镜检查作为黄金标准。 目的2：利用受试者的工作特性评价两种定量拟合的诊断准确性 (ROC)分析。 目的3：评估与每个设备的假阳性和假阴性匹配结果相关的因素。 这些发现将为未来提供有关具有最佳测试特性的匹配的基本信息 扩大适合度的使用，对于实现降低发病率和死亡率的长期目标至关重要 来自中国铁路总公司。FIT更容易被患者接受，将允许更高的筛查率，并将降低成本，因为 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。