Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients

Data de publicação:

Autores da FMUP

  • Valdemar De Jesus Conde Máximo

    Autor

  • Ana Paula Soares Dias Ferreira

    Autor

Participantes de fora da FMUP

  • Sieverink, CA
  • Batista, RPM
  • Prazeres, HJM
  • Vinagre, J
  • Sampaio, C
  • Leao, RR
  • Witjes, JA

Unidades de investigação

Abstract

The costly and burdensome nature of the current follow-up methods in non-muscle-invasive bladder cancer (NMIBC) drives the development of new methods that may alternate with regular cystoscopy and urine cytology. The Uromonitor-V2 (R) is a new urine-based assay in the detection of hotspot mutations in three genes (TERT, FGFR3, and KRAS) for evaluation of disease recurrence. The aim of this study was to investigate the Uromonitor-V2 (R)'s performance in detecting NMIBC recurrence and compare it with urine cytology. From February 2018 to September 2019 patients were enrolled. All subjects underwent a standard-of-care (SOC) cystoscopy, either as part of their follow-up for NMIBC or for a nonmalignant urological pathology. Urine cytology was performed in NMIBC patients. Out of the 105 patients enrolled, 97 were eligible for the study. Twenty patients presented nonmalignant lesions, 29 had a history of NMIBC with disease recurrence, and 49 had a history of NMIBC without recurrence. In NMIBC, the Uromonitor-V2 (R) displayed a sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 93.1%, 85.4%, 79.4%, and 95.3%, respectively. Urine cytology was available for 52 patients, and the sensitivity, specificity, PPV, and NPV were 26.3%, 90.9%, 62.5%, and 68.2%, respectively. With its high NPV of 95.3%, the Uromonitor-V2 (R) revealed promising properties for the follow-up of patients with NMIBC.

Dados da publicação

ISSN/ISSNe:
2075-4418, 2075-4418

Diagnostics  MDPI AG

Tipo:
Article
Páginas:
745-
Link para outro recurso:
www.scopus.com

Citações Recebidas na Web of Science: 18

Citações Recebidas na Scopus: 35

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Keywords

  • biomarkers; bladder cancer; cystoscopy; cytology; follow-up; non-muscle-invasive bladder cancer; recurrence; urine test

Financiamento

Proyectos asociados

Mitochondrial complex II genetic characterization and enzymatic expression profile in tumours of the adrenal cortex and medulla

Investigador Principal: Valdemar de Jesus Conde Máximo

Estudo Clínico Académico (Mitochondrial) . 2020

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