Urinary DNA Methylation Test for Bladder Cancer Diagnosis

作者：In Gab Jeong, Sung‐Cheol Yun, Hong Koo Ha, Sung Gu Kang, Sangchul Lee, Sungchan Park, Hyun Hwan Sung, Sun Il Kim, Eu Chang Hwang, Kyung Cheol Moon, Cheol Hun Kwak · 发表于：JAMA Oncology · 年份：2025 · DOI：10.1001/jamaoncol.2024.6160 · 被引用次数：24 · 研究领域：Bladder and Urothelial Cancer Treatments、Urinary and Genital Oncology Studies、Epigenetics and DNA Methylation

Importance: An accurate noninvasive biomarker test is needed for the early diagnosis of bladder cancer. Objective: To evaluate the performance of a urinary DNA methylation test (PENK methylation) and compare its diagnostic accuracy with that of the nuclear matrix protein 22 (NMP22) test or urine cytology test. Design, Setting, and Participants: In this prospective multicenter study at 10 sites in the Republic of Korea, individuals 40 years and older with hematuria undergoing cystoscopy within 3 months between March 11, 2022, and May 30, 2024, participated. The study participants were evaluated for bladder cancer using a urinary DNA methylation test. Exposure: Urinary DNA methylation test, NMP22 test, and urine cytology test. Main Outcomes and Measures: The primary outcomes were the sensitivity and specificity of the urinary DNA methylation test for high-grade or invasive bladder cancer. Secondary objectives included the accuracy of the test for overall bladder cancer (all stages and grades) and the comparison of sensitivities and specificities for bladder cancer between the urinary DNA methylation test and the NMP22 test or urine cytology test. Results: Among the 1099 participants, 614 (55.9%) were male; participants had a mean (SD) age of 65 (10) years. Of the 1099 participants, 219 and 176 participants had bladder cancer and high-grade or invasive bladder cancer, respectively. The urinary DNA methylation test had sensitivity and specificity for high-grade or invasive bladde...