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Original research
Methylation study of the Paris system for reporting urinary (TPS) categories
  1. Francesco Pierconti1,
  2. Maurizio Martini1,
  3. Tonia Cenci1,
  4. Vincenzo Fiorentino1,
  5. Emilio Sacco2,
  6. Riccardo Bientinesi2,
  7. Dario Pugliese2,
  8. Roberto Iacovelli3,
  9. Giovanni Schinzari3,
  10. Luigi Maria Larocca1,
  11. Pier Francesco Bassi2
  1. 1 Division of Anatomic Pathology and Histology, Catholic University of the Sacred Heart, “Agostino Gemelli” School of Medicine, Rome, Italy
  2. 2 Department of Urology, Catholic University of the Sacred Heart, “Agostino Gemelli” School of Medicine, Rome, Italy
  3. 3 Department of Oncology, Catholic University of the Sacred Heart, “Agostino Gemelli” School of Medicine, Rome, Italy, Rome, Italy
  1. Correspondence to Dr Francesco Pierconti, Division of Anatomic Pathology and Histology, Catholic University of the Sacred Heart, “Agostino Gemelli” School of Medicine, Rome 00136, Italy; francesco.pierconti{at}unicatt.it

Abstract

Aims Bladder EpiCheck is one of several urinary tests studied to identify bladder tumours and analyses 15 methylation biomarkers determining bladder cancer presence on the basis of methylation profile.

Methods 374 patients diagnosed with high-grade non-muscle invasive bladder cancer were treated and followed for 1 year with voided urine cytology and white-light cystoscopy and biopsies according to European Association of Urology Guidelines. 268 cases were diagnosed with high-grade papillary carcinoma, while 106 cases were carcinoma in situ. Bladder EpiCheck test was performed together with cytology in all cases.

Results Comparing cytological categories of negative for high-grade urothelial carcinoma (NHGUC) and atypical urothelial cells (AUCs), we found that an EpiScore <60 correlates with NHGUC (p=0.0003, Fisher’s exact test), while comparing AUC and suspicious for high-grade urothelial carcinoma (SHGUC) or SHGUC and high-grade urothelial carcinoma (HGUC) categories, an EpiScore ≥60 correlates with SHGUC and HGUC, respectively (p=0.0031 and p=0.0027, Fisher’s exact test). In each TPS category, we found that sensitivity, specificity, Positive Predicitve Value (PPV) and Negative Predictive Value (NPV) of the Bladder EpiCheck test in HGUC category were higher than those observed in SHGUC group (sensitivity=98%, specificity=100%, NPV=85.7%, PPV=100% vs sensitivity=86.6%, specificity=52.3%, NPV=84.6%, PPV=56.5%).

Conclusions Analysing methylation study results, we demonstrated that different TPS cytological categories also carry a distinct molecular signature. Moreover, our results confirm that cytological categories SHGUC and HGUC are different entities also from a molecular point of view and should continue to represent distinct groups in TPS.

  • carcinoma
  • urinary bladder
  • DNA
  • urine

https://doi.org/10.1136/jclinpath-2020-206633

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    Footnotes

    • Handling editor Runjan Chetty.

    • Contributors All the authors contributed to the writing of paper.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request.