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Original Study| Volume 20, ISSUE 4, e271-e275, August 2022

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The Role of Bladder Epicheck Test In Follow-Up of Patients with Non-Muscle Invasive Bladder Cancer

Published:March 16, 2022DOI:https://doi.org/10.1016/j.clgc.2022.03.009

      Highlights

      • New non-invasive diagnostic tool are needed for management of NMIBC.
      • Urinary cytology has some limitation due to confounding factors such as inflammation and due to interobserver variability.
      • Methylation test have been already shown their sensitivity and their specificity in patients with NMIBC.
      • This test could overcome the limits of urinary cytology and could be incorporated in the management of patients in follow-up for NMIBC.

      Abstract

      Introduction

      EpiCheck is a new urinary test that analyses DNA methylation biomarkers in order to identify high-risk urothelial cancer

      Materials and methods

      A prospective single centre study was performed. We analysed Epicheck results in a population of 231 patients in follow-up for non-muscle invasive bladder cancer. The primary endpoint was to evaluate sensitivity and specificity of Epicheck in detecting any type of bladder cancer recurrence. The secondary endpoint was to evaluate specificity and sensitivity of Epicheck in patients with high-risk recurrence and in patients recently treated with endovesical therapy (< 3 months).

      Results

      Negative predictive value (NPV) for cytology was 83 % while for bladder Epicheck it was 89 %, while positive predictive value (PPV) was 67 % and 73 % for cytology and Epicheck respectively. Considering only high grade non muscle invasive bladder cancer the sensitivity of Epicheck was 91 % and for cytology was 81 %, specificity was 85 % and 83 % and negative predictive value of Epicheck outreached 96 % compared to 92 % of cytology. Among patients with an ongoing or recent endovesical treatment it appears that sensitivity of Epicheck was 88% % compared to 73 % of cytology, specificity was 97 % and 85 % and NPV was 92 % compared to 82 % for cytology.

      Conclusion

      The EpiCheck (test showed very high diagnostic values, higher than the currently, gold standard. The test might clinically improve the BCa management in terms of, reduced number of inconclusive/suspicious reports of cytology and endoscopy, reduced number of further examinations, reduced associated patient and economic

      Keywords

      Abbreviations:

      NMIBC (Non muscle invasive bladder cancer), BCG (Bacillus of Calmette e Guerìn), EMDA (Electromotive drug administration), MMC (Mitomycin C)
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