Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America; Department of Epidemiology, College of Public Health, University of Iowa, Iowa City, IA, United States of America; Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA, United States of America.
Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City, IA, United States of America.
Contemp Clin Trials. 2021 Jul;106:106430. doi: 10.1016/j.cct.2021.106430. Epub 2021 May 8.
There are nearly 50,000 colorectal cancer (CRC) deaths in the United States each year. CRC is curable if detected in its early stages. Fecal immunochemical tests (FITs) can detect precursor lesions and many can be analyzed at the point-of-care (POC) in physician offices. However, there are few data to guide test selection. Broader use of FITs could make CRC screening more accessible, especially in resource-poor settings.
A total of 3600 racially and ethnically diverse individuals aged 50 to 85 years having either a screening or surveillance colonoscopy will be recruited. Each participant will complete five FITs on a single stool sample. Test characteristics for each FIT for advanced colorectal neoplasia (ACN) will be calculated using colonoscopy as the gold standard.
We have complete data from a total of 2990 individuals. Thirty percent are Latino and 5.3% are black/African American. We will present full results once the study is completed.
Our focus in this study is how well FITs detect ACN, using colonoscopy as the gold standard. Four of the five FITs being used are POC tests. Although FITs have been shown to have acceptable performance, there is little data to guide which ones have the best test characteristics and colonoscopy is the main CRC screening test used in the United States. Use of FITs will allow broader segments of the population to access CRC screening because these tests require no preparation, are inexpensive, and can be collected in the privacy of one's home. Increasing CRC screening uptake will reduce the burden of advanced adenomas and colorectal cancer.
美国每年有近 50,000 人死于结直肠癌（CRC）。如果在早期发现，CRC 是可以治愈的。粪便免疫化学检测（FIT）可以检测到癌前病变，并且许多可以在医生办公室的即时检测（POC）点进行分析。然而，目前几乎没有数据可以指导测试选择。更广泛地使用 FIT 可以使 CRC 筛查更容易获得，特别是在资源匮乏的环境中。
将招募 3600 名年龄在 50 至 85 岁之间的不同种族和族裔的个体，他们要么正在接受筛查，要么正在接受结肠镜检查。每个参与者将在单个粪便样本上完成五次 FIT。使用结肠镜检查作为金标准，计算每个 FIT 对高级结直肠肿瘤（ACN）的测试特征。
我们已经从总共 2990 名个体中获得了完整的数据。30%是拉丁裔，5.3%是黑人/非裔美国人。一旦研究完成，我们将提供完整的结果。
我们在这项研究中的重点是 FIT 检测 ACN 的性能如何，使用结肠镜检查作为金标准。正在使用的五种 FIT 中有四种是即时检测测试。虽然 FIT 已被证明具有可接受的性能，但几乎没有数据可以指导哪些具有最佳的测试特征，并且结肠镜检查是美国主要的 CRC 筛查测试。使用 FIT 将使更广泛的人群能够获得 CRC 筛查，因为这些测试不需要准备，价格便宜，并且可以在一个人的家中进行。增加 CRC 筛查的参与率将减轻晚期腺瘤和结直肠癌的负担。
