@article{c2d00d9af656474e9e0c45f5e734470b,
title = "Endometrial Cancer Detection Using a Cervical DNA Methylation Assay (MPap) in Women with Abnormal Uterine Bleeding: A Multicenter Hospital-Based Validation Study",
abstract = "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.",
keywords = "abnormal uterine bleeding, DNA methylation biomarker, early detection of endometrial cancer, MPap, triage tool",
author = "Wen, {Kuo Chang} and Huang, {Rui Lan} and Chen, {Lin Yu} and Wu, {Tzu I.} and Lu, {Chien Hsing} and Chu, {Tang Yuan} and Ou, {Yu Che} and Wu, {Chen Hsuan} and Hsu, {Shih Tien} and Ding, {Dah Ching} and Chu, {Ling Hui} and Chen, {Chien Wen} and Chang, {Heng Cheng} and Liu, {Yu Shu} and Wang, {Hui Chen} and Weng, {Yu Chun} and Su, {Po Hsuan} and Hao Lin and Lai, {Hung Cheng}",
note = "Funding Information: This work was supported by a grant from the Ministry of Health and Welfare (MOHW105–TDU–PB–212–000007), the Ministry of Science and Technology of Taiwan (MOST106–3114–B–038–003, MOST107–2321–B–038–003, MOST107–2321–B–038–006, MOST110–2314–B–038–059, and MOST111–2314–B–038–110–MY2), and Shuang Ho Hospital-Taipei Medical University (106TMU-SHH–14, TMU108-AE1-B54). Funding Information: The application of the MPap test was patented and licensed by Guzip Biomarkers Corporation. The authors Heng-Cheng Chang and Yu-Shu Liu, are employed by Guzip Biomarkers Corporation. The author Dr. Hung-Cheng Lai is the inventor for three patents on a method for cancer diagnosis and prognosis, a method for tumor detection, and a method for tumor detection II. Taipei Medical University owns the intellectual property. The work was supported by the grant from the Ministry of Health and Welfare, the Ministry of Science and Technology of Taiwan, and Shuang Ho Hospital-Taipei Medical University. The sponsors had no role in the design and conduct of the study; the collection, management, analysis, and interpretation of the data; the preparation, review, or approval of the manuscript; or the decision to submit the manuscript for publication. All data may be shared, subject to our institute{\textquoteright}s data sharing policy, which has been approved by the Institutional Review Boards (IRBs). Publisher Copyright: {\textcopyright} 2022 by the authors.",
year = "2022",
month = sep,
doi = "10.3390/cancers14174343",
language = "English",
volume = "14",
journal = "Cancers",
issn = "2072-6694",
publisher = "Multidisciplinary Digital Publishing Institute (MDPI)",
number = "17",
}
