Performance of the Bladder EpiCheck™ Methylation Test for Patients Under Surveillance for Non-muscle-invasive Bladder Cancer: Results of a Multicenter, Prospective, Blinded Clinical Trial.

The highly frequent strategy of surveillance for non-muscle-invasive bladder cancer (NMIBC) involves cystoscopy and cytology. Urine assays currently available have not shown performance sufficient to replace the current gold standard for follow-up, which would require a very high negative predictive value (NPV), especially for high-grade tumors. Bladder EpiCheck (BE) is a novel urine assay that uses 15 proprietary DNA methylation biomarkers to assess the presence of bladder cancer.

To assess the performance of BE for NMIBC recurrence.

This was a blinded, single-arm, prospective multicenter study. The inclusion criteria were age ≥22 yr, urothelial carcinoma (UC) being monitored cystoscopically at 3-mo intervals, all UC resected within 12 mo, able to produce 10ml of urine, and able to consent.

The BE test characteristics were calculated and compared to cytology and cystoscopy results confirmed by pathology.

Out of 440 patients recruited, 353 were eligible for the performance analysis. Overall sensitivity, specificity, NPV, and positive predictive value were 68.2%, 88.0%, 95.1%, and 44.8%, respectively. Excluding low-grade (LG) Ta recurrences, the sensitivity was 91.7% and NPV was 99.3%. The area under receiver operating characteristic (ROC) curves with and without LG Ta lesions was 0.82 and 0.94, respectively.

In follow-up of NMIBC patients, the BE test showed an overall high NPV of 95.1%, and 99.3% when excluding LG Ta recurrences. With high specificity of 88.0%, the test could be incorporated in NMIBC follow-up since high-grade recurrences would be instantly detected with high confidence. Thus, the current burden of repeat cystoscopies and cytology tests could be reduced.

The Bladder EpiCheck urine test has a clinically relevant and high negative predictive value. Its use in clinical routine could reduce the number of follow-up cystoscopies, and thus associated patient and financial burdens.

European urology oncology. 2018 Jul 17 [Epub]

J Alfred Witjes, Juan Morote, Erik B Cornel, Georgios Gakis, F Johannes P van Valenberg, Fernando Lozano, Itay A Sternberg, Ellen Willemsen, Miriam L Hegemann, Yossi Paitan, Ilan Leibovitch

Department of Urology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. Electronic address: ., Department of Urology, Hospital Universitari Vall d'Hebron Hospital, Barcelona, Spain., Department of Urology, ZGT Medical Center, Hengelo, The Netherlands., Department of Urology and Pediatric Urology, University Hospital of Würzburg, Würzburg, Germany., Department of Urology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands., Department of Urology, Meir Medical Center, Kfar Saba, Israel., Department of Urology, Sindelfingen-Böblingen Hospital, Sindelfingen, Germany., Clinical Microbiology Laboratory, Meir Medical Center, Kfar Saba, Israel.

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