gms | German Medical Science

45. Gemeinsame Tagung der Österreichischen Gesellschaft für Urologie und Andrologie und der Bayerischen Urologenvereinigung

09.05. - 11.5.2019, Wien, Österreich

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Diagnostic predictive value of the Epicheck Test in the follow-up of patients with non muscle invasice bladder cancer (NMIBC)

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  • presenting/speaker Helmuth Walter Schuster - Südtiroler Sanitätsbetrieb
  • Emanuela Trenti - Central Hospital of Bolzano, Department of Urology
  • Carolina D’Elia - Central Hospital of Bolzano, Department of Urology
  • Christine Mian - Central Hospital of Bolzano, Department of Pathology
  • Christine Schwienbacher - Central Hospital of Bolzano, Department of Pathology
  • Esther Hanspeter - Central Hospital of Bolzano, Department of Pathology
  • Alexander Pycha - Luzerner Kantonsspital, Department of Urology
  • Stephan Degener - Helios-Klinikum Wuppertal, Witten Herdecke University, Department of Urology
  • Hansjörg Danuser - Luzerner Kantonsspital, Department of Urology
  • Stephan Roth - Helios-Klinikum Wuppertal, Witten Herdecke University, Department of Urology
  • Armin Pycha - Central Hospital of Bolzano, Department of Urology

Österreichische Gesellschaft für Urologie und Andrologie. Bayerische Urologenvereinigung. 45. Gemeinsame Tagung der Österreichischen Gesellschaft für Urologie und Andrologie und der Bayerischen Urologenvereinigung. Wien, 09.-11.05.2019. Düsseldorf: German Medical Science GMS Publishing House; 2019. Doc19oegu025

doi: 10.3205/19oegu025, urn:nbn:de:0183-19oegu0252

Veröffentlicht: 8. April 2019

© 2019 Schuster et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.

Gliederung

Text

Introduction: Due to the limitations of cytology and cystoscopy in the diagnosis of bladder cancer (BC), a urinary marker with high sensitivity and specificity could be an additional tool for monitoring low grade (LG) and high grade (HG) tumors. The Bladder Epicheck Test (Nucleix ltd., Rehovot, Israel) is a new urinary marker based on DNA methylation changes associated with BC in a panel of 15 genomic biomarkers. The aim of our study was to evaluate the diagnostic accuracy of Bladder Epicheck Test in the follow up of NMIBC and to compare it with urinary cytology, cystoscopy and histology.

Materials and methods: 191 patients under follow up for NMIBC were included in this prospective study. Samples were analyzed with Bladder Epicheck Test and urinary cytology. Subsequently, the patients underwent cystoscopy and if positive, a transurethral resection of the bladder.

Cytologies were evaluated according to the Paris system of reporting cytology. For the Bladder Epicheck Test a software calculated the EpiScore, a number between 0 and 100 representing the overall methylation level of the sample. An EpiScore >60 was considered positive.

Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) of both tests were calculated using cystoscopy/histology as gold standard.

Results: 191 patients (mean age 72.2 years, range 43-94) were followed up for NMIBC (121 LG, 70 HG). 25 patients (13.1%) were excluded due to insufficient DNA in the Bladder Epicheck analysis. Of the remaining 165 patients, 45 had tumor recurrence (29 LG, 16 HG). Cytology was positive in 14/39 (35.9%), Bladder Epicheck in 27/39 (69.2%) patients. For cytology the sensitivity increased from 10.3% in LG up to 68.7% in HG tumors, for Bladder Epicheck from 44.8% up to 87.5% respectively. Of 120 cystoscopically/histologically negative patients, 115 were cytologically negative (specificity 95.8%). Bladder Epicheck Test was correctly negative in 101/120 patients (specificity 84.2%). PPV for cytology was 73.7% and 58.7% for Bladder Epicheck, NPV was 82.1% and 89.4% respectively.

Conclusion: Sensitivity of the Bladder Epicheck Test was significantly higher than for cytology. The test showed a high specificity, which however could not reach the value of cytology, and a high NPV.