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You have accessJournal of UrologyCME1 Apr 2023LBA02-02 A PROSPECTIVE STUDY COMPARING PENK METHYLATION, NMP22, AND CYTOLOGY FOR DETECTING BLADDER CANCER RECURRENCE AFTER TRANSURETHRAL RESECTION Hyunho Han, Youngheun Jo, Ji Eun Heo, Jong Soo Lee, Won Sik Jang, Seung Hwan Lee, Won Sik Ham, Young Deuk Choi, Tae Jeong Oh, and Sungwhan An Hyunho HanHyunho Han More articles by this author , Youngheun JoYoungheun Jo More articles by this author , Ji Eun HeoJi Eun Heo More articles by this author , Jong Soo LeeJong Soo Lee More articles by this author , Won Sik JangWon Sik Jang More articles by this author , Seung Hwan LeeSeung Hwan Lee More articles by this author , Won Sik HamWon Sik Ham More articles by this author , Young Deuk ChoiYoung Deuk Choi More articles by this author , Tae Jeong OhTae Jeong Oh More articles by this author , and Sungwhan AnSungwhan An More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000003361.02AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The objective of this study is to evaluate the efficacy of a PENK methylation test in detecting recurrent non-muscle invasive bladder cancer (NMIBC) and to compare its performance to that of NMP22 and cytology in a prospective pilot study. METHODS: A total of 188 patients with a history of NMIBC and scheduled for cystoscopy surveillance after TURBT were enrolled in the study. Urine samples were collected and analyzed using the Linear Target Enrichment (LTE)-quantitative methylation-specific real-time PCR (qMSP) test (mePENK-LTE-qMSP) for measuring PENK methylation, as well as the NMP22 test. The reference standard for NMIBC was cystoscopy and pathology. The mePENK-LTE-qMSP test was conducted with a cut-off value determined by ROC analysis of 32.0, and results were classified as positive or negative. The cystoscopy results were classified as recurrence or non-recurrence, and recurrences were further subcategorized as progression or non-progression. The clinical performance of the mePENK-LTE-qMSP test was analyzed and compared to NMP22 and cytology. RESULTS: The mePENK-LTE-qMSP test had a sensitivity of 78.4% (40/51) and a specificity of 85.0% (108/127) in detecting NMIBC. It had higher sensitivity than NMP22 (p=0.0106) or cytology (p<0.001), while its specificity was not significantly different from NMP22 (p=0.6076) but inferior to cytology (p=0.0001). Subgroup analysis demonstrated that the mePENK-LTE-qMSP test had a sensitivity of 46.7% (7/15) and a specificity of 96.6% (28/29) in detecting NMIBC among low- and intermediate-risk patients. It also had a sensitivity of 91.2% (31/34) and a specificity of 81.0% (68/84) in detecting NMIBC among high-risk patients. Patients who were recurrence-free at the time of diagnosis had follow-up cystoscopy, at a median follow-up duration of 223 days (n=71). The mePENK test positive patients (n=14) had a significantly shorter recurrence-free survival than test-negative patients (n=57) (245 days vs 503 days, hazard ratio=9.4 (95% CI 2.4 to 35.9), p<0.0001). CONCLUSIONS: The mePENK-LTE-qMSP test demonstrated high sensitivity and specificity in detecting recurrent NMIBC and accurately excluded non-recurring or non-progressing NMIBC during surveillance. Additionally, it was able to predict NMIBC recurrence before recognition by cystoscopy. Source of Funding: Genomictree, Inc. of South Korea sponsored this study © 2023 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 209Issue Supplement 4April 2023Page: e1186 Advertisement Copyright & Permissions© 2023 by American Urological Association Education and Research, Inc.MetricsAuthor Information Hyunho Han More articles by this author Youngheun Jo More articles by this author Ji Eun Heo More articles by this author Jong Soo Lee More articles by this author Won Sik Jang More articles by this author Seung Hwan Lee More articles by this author Won Sik Ham More articles by this author Young Deuk Choi More articles by this author Tae Jeong Oh More articles by this author Sungwhan An More articles by this author Expand All Advertisement PDF downloadLoading ...

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