Evaluation of Sensitive Urine DNA-Based PENK Methylation Test for Detecting Bladder Cancer in Patients with Hematuria

膀胱镜检查 尿 膀胱癌 金标准(测试) 医学 曲线下面积 甲基化 内科学 癌症 DNA甲基化 泌尿科 接收机工作特性 预测值 试验预测值 肿瘤科 泌尿系统 DNA 生物 基因 基因表达 遗传学
作者
Tae Jeong Oh,Ji‐Yong Lee,Yangyei Seo,Min A Woo,Jae Sung Lim,Yong Gil Na,Ki Hak Song,Bo‐Ram Bang,Justin Junguek Lee,Ju Hyun Shin,Sungwhan An
出处
期刊:The Journal of Molecular Diagnostics [Elsevier BV]
卷期号:25 (9): 646-654 被引量:6
标识
DOI:10.1016/j.jmoldx.2023.05.003
摘要

Hematuria is a prevalent symptom associated with bladder cancer (BC). However, the invasiveness and cost of cystoscopy, the current gold standard for BC diagnosis in patients with hematuria, necessitate the development of a sensitive and accurate noninvasive test. This study introduces and validates a highly sensitive urine-based DNA methylation test. The test improves sensitivity in detecting PENK methylation in urine DNA using linear target enrichment followed by quantitative methylation-specific PCR. In a case-control study comprising 175 patients with BC and 143 patients without BC with hematuria, the test's optimal cutoff value was determined by distinguishing between two groups, achieved an overall sensitivity of 86.9% and a specificity of 91.6%, with an area under the curve of 0.892. A prospective validation clinical study involving 366 patients with hematuria scheduled for cystoscopy assessed the test's performance. The test demonstrated an overall sensitivity of 84.2% in detecting 38 cases of BC, a specificity of 95.7%, and an area under the curve of 0.900. Notably, the sensitivity for detecting Ta high grade and higher stages of BC reached 92.3%. The test's negative predictive value was 98.2%, and the positive predictive value was 68.7%. These findings highlight the potential of the PENK methylation in urine DNA using linear target enrichment followed by quantitative methylation-specific PCR test in urine as a promising molecular diagnostic tool for detecting primary BC in patients with hematuria, which may reduce the need for cystoscopy.
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