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 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, Yushu Liu, Hui-Chen Wang, Yu‐Chun Weng, Po‐Hsuan Su, Hao Lin, Hung-Cheng Lai
Abstract
BACKGROUND: We describe a DNA methylation assay, named MPap test, using cervical scraping as an alternative technique for endometrial cancer detection. METHODS: ) 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.