背景:我们描述了一种DNA甲基化测定,名为MPAP测试,使用宫颈刮擦作为子宫内膜癌检测的替代技术。
方法:多中心医院,我们进行了两阶段验证研究,以验证MPap测试的癌症检测性能.从两个基因(BHLHE22,CDO1)的DNA甲基化状态确定MPap值,并结合其他两个临床变量(年龄,BMI)。在阶段1中建立MPap值的截止阈值并在阶段2中验证。共有592名异常子宫出血的妇女从台湾的五个医疗中心进行登记。
结果:在第一阶段,灵敏度,特异性,MPap检测子宫内膜癌的阳性预测值和阴性预测值分别为92.9%,71.5%,39.8%,和98.0%,分别。这些值在第二阶段进行了验证,为92.5%,73.8%,40.2%,98.1%。此外,MPap在检测子宫内膜癌的敏感性和阴性预测值方面优于经阴道超声。当我们在台湾国民健康保险数据集中应用MPap对子宫内膜癌检测进行分诊的算法时,我们发现它可以减少69~73%的侵入性手术。
结论:MPap可能为子宫内膜癌的检测提供了可行的替代方法,并且可以被视为一种分类测试,以减少不必要的侵入性程序。
BACKGROUND: We describe a DNA methylation assay, named MPap test, using cervical scraping as an alternative technique for endometrial cancer detection.
METHODS: A multicenter hospital-based, two-stage validation study was conducted to validate the cancer detection performance of the MPap test. The MPap value was determined from the DNA methylation status of two genes (BHLHE22, CDO1) and combined with two other clinical variables (age, BMI). The cutoff threshold of the MPap value was established in stage 1 and validated in stage 2. A total of 592 women with abnormal uterine bleeding were enrolled from five medical centers throughout Taiwan.
RESULTS: In stage 1, the sensitivity, specificity, and positive and negative predictive values of the MPap test for detecting endometrial cancer were 92.9%, 71.5%, 39.8%, and 98.0%, respectively. These values were validated in stage 2, being 92.5%, 73.8%, 40.2%, and 98.1%. Moreover, MPap outperformed transvaginal ultrasound in sensitivity and negative predictive values for detecting endometrial cancer. When we applied the algorithm for triage of endometrial cancer detection by MPap in the Taiwan National Health Insurance dataset, we found that it may reduce invasive procedures by 69~73%.
CONCLUSIONS: MPap may provide a feasible alternative for endometrial cancer detection and can be considered as a triage test to reduce unnecessary invasive procedures.