European Translational Oncology Prevention and Screening (EUTOPS) Institute, Universität Innsbruck, Innsbruck, Austria.
Institute for Biomedical Aging Research, Universität Innsbruck, Innsbruck, Austria.
J Clin Oncol. 2022 Nov 20;40(33):3828-3838. doi: 10.1200/JCO.22.00266. Epub 2022 Aug 24.
Endometrial cancer (EC) incidence has been rising over the past 10 years. Delays in diagnosis reduce survival and necessitate more aggressive treatment. We aimed to develop and validate a simple, noninvasive, and reliable triage test for EC to reduce the number of invasive diagnostic procedures and improve patient survival.
We developed a test to screen and triage women with suspected EC using 726 cervical smear samples from women with and without EC, and validated the test in 562 cervicovaginal samples using three different collection methods (cervical smear: n = 248; vaginal swab: n = 63; and self-collection: n = 251) and four different settings (case/control: n = 388; cohort of women presenting with postmenopausal bleeding: n = 63; a cohort of high-risk women with Lynch syndrome: n = 25; and a nested case/control setting from a screening cohort and samples taken up to 3 years before EC diagnosis: n = 86).
We describe the omen's cancer risk entification - uantitative polymerase chain reaction test for ndometrial ancer (WID-qEC), a three-marker test that evaluates DNA methylation in gene regions of and . In cervical, self-collected, and vaginal swab samples derived from symptomatic patients, it detected EC with sensitivities of 97.2% (95% CI, 90.2 to 99.7), 90.1% (83.6 to 94.6), and 100% (63.1 to 100), respectively, and specificities of 75.8% (63.6 to 85.5), 86.7% (79.3 to 92.2), and 89.1% (77.8 to 95.9), respectively. The WID-qEC identified 90.9% (95% CI, 70.8 to 98.9) of EC cases in samples predating diagnosis up to 1 year. Test performance was similar across menopausal status, age, stage, grade, ethnicity, and histology.
The WID-qEC is a noninvasive reliable test for triage of women with symptoms suggestive of ECs. Because of the potential for self-collection, it could improve early diagnosis and reduce the reliance for in-person visits.
子宫内膜癌（EC）的发病率在过去 10 年中一直在上升。诊断延迟会降低生存率，并需要更积极的治疗。我们旨在开发和验证一种简单、无创且可靠的 EC 分诊测试，以减少侵入性诊断程序的数量并提高患者生存率。
我们开发了一种使用来自患有和不患有 EC 的女性的 726 个宫颈涂片样本筛查和分诊疑似 EC 女性的测试，并使用三种不同的采集方法（宫颈涂片：n = 248；阴道拭子：n = 63；和自我采集：n = 251）和四种不同的设置（病例/对照：n = 388；绝经后出血就诊的女性队列：n = 63；林奇综合征高危女性队列：n = 25；和筛查队列中的嵌套病例/对照设置和在 EC 诊断前长达 3 年采集的样本：n = 86）验证了该测试。
我们描述了 omen's cancer risk entification - uantitative polymerase chain reaction test for ndometrial ancer (WID-qEC)，这是一种三标志物测试，评估了 和 基因区域的 DNA 甲基化。在来自有症状患者的宫颈、自我采集和阴道拭子样本中，它检测 EC 的敏感性分别为 97.2%（95%CI，90.2 至 99.7）、90.1%（83.6 至 94.6）和 100%（63.1 至 100），特异性分别为 75.8%（63.6 至 85.5）、86.7%（79.3 至 92.2）和 89.1%（77.8 至 95.9）。WID-qEC 在距诊断时间长达 1 年的时间内，在样本中鉴定出 90.9%（95%CI，70.8 至 98.9）的 EC 病例。在绝经状态、年龄、分期、分级、种族和组织学方面，测试性能相似。
WID-qEC 是一种用于分诊有 EC 症状女性的非侵入性可靠测试。由于自我采集的可能性，它可以改善早期诊断并减少对面对面就诊的依赖。
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