Diagnostic accuracy of urinary PENK methylation test for urothelial and other cancers: A prospective study

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Abstract
The methylated PENK gene is known to be highly expressed in the urine of patients with bladder cancer. Recent large-scale multicenter studies have confirmed the robust diagnostic performance of urinary PENK methylation, reporting high sensitivity and specificity for bladder cancer detection. However, its association with other cancers remains unclear. This prospective study aimed to determine the diagnostic accuracy of the urinary PENK methylation test for urothelial carcinoma among patients with 13 different cancer types. Between August 2022 and April 2023, 183 patients were enrolled, including 17 with urothelial carcinoma (eight bladder cancer and nine upper tract urothelial carcinoma) and 166 with other cancers. The urinary PENK methylation test showed an overall sensitivity of 94.1% (87.5% for bladder cancer and 100% for UTUC) and a specificity of 95.8% when patients with non-urothelial cancers were used as the control group. Positive urinary PENK methylation test was obtained for two patients with cervical cancer (25.0%), 2 with colorectal cancer (10.5%), and one patient each with esophageal (4.8%), liver (5.0%), and kidney (5.3%) cancer. These findings confirm the high sensitivity and specificity of the urinary PENK methylation test for detecting urothelial carcinoma and support its potential as a non-invasive biomarker.

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