Wen Kuo-Chang, Huang Rui-Lan, Chen Lin-Yu, Wu Tzu-I, Lu Chien-Hsing, Chu Tang-Yuan, Ou Yu-Che, Wu Chen-Hsuan, Hsu Shih-Tien, Ding Dah-Ching, Chu Ling-Hui, Chen Chien-Wen, Chang Heng-Cheng, Liu Yu-Shu, Wang Hui-Chen, Weng Yu-Chun, Su Po-Hsuan, Lin Hao, Lai Hung-Cheng
Department of Obstetrics and Gynecology, School of Medicine, College of Medicine, Taipei Medical University, Taipei 110, Taiwan.
Department of Obstetrics and Gynecology, Shuang Ho Hospital, Taipei Medical University, New Taipei City 235, Taiwan.
Cancers (Basel). 2022 Sep 5;14(17):4343. doi: 10.3390/cancers14174343.
We describe a DNA methylation assay, named MPap test, using cervical scraping as an alternative technique for endometrial cancer detection.
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 () 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.
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%.
MPap may provide a feasible alternative for endometrial cancer detection and can be considered as a triage test to reduce unnecessary invasive procedures.
我们描述了一种名为MPap检测的DNA甲基化检测方法，该方法使用宫颈刮片作为子宫内膜癌检测的替代技术。
进行了一项基于多中心医院的两阶段验证研究，以验证MPap检测的癌症检测性能。MPap值由两个基因的DNA甲基化状态确定，并结合另外两个临床变量（年龄、体重指数）。MPap值的临界阈值在第1阶段确定，并在第2阶段进行验证。总共从台湾各地的五个医疗中心招募了592名子宫异常出血的女性。
在第1阶段，MPap检测子宫内膜癌的敏感性、特异性、阳性和阴性预测值分别为92.9%、71.5%、39.8%和98.0%。这些值在第2阶段得到验证，分别为92.5%、73.8%、40.2%和98.1%。此外，在检测子宫内膜癌的敏感性和阴性预测值方面，MPap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检测子宫内膜癌的分诊算法时，我们发现它可以减少69%至73%的侵入性检查。
MPap可能为子宫内膜癌检测提供一种可行的替代方法，并可被视为一种分诊检测，以减少不必要的侵入性检查。
