Endometrial Cancer Detection Using a Cervical DNA Methylation Assay (MPap) in Women with Abnormal Uterine Bleeding: A Multicenter Hospital-Based Validation Study

Kuo Chang Wen, Rui Lan Huang, Lin Yu Chen, Tzu I. Wu, Chien Hsing Lu, Tang Yuan Chu, Yu Che Ou, Chen Hsuan Wu, Shih Tien Hsu, Dah Ching Ding, Ling Hui Chu, Chien Wen Chen, Heng Cheng Chang, Yu Shu Liu, Hui Chen Wang, Yu Chun Weng, Po Hsuan Su, Hao Lin, Hung Cheng Lai

研究成果: 雜誌貢獻文章同行評審

摘要

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.

原文英語
文章編號4343
期刊Cancers
14
發行號17
DOIs
出版狀態已發佈 - 9月 2022

ASJC Scopus subject areas

  • 腫瘤科
  • 癌症研究

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