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

Autores da FMUP
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
- Tipo:
- Article
- Páginas:
- 745-
- Link para outro recurso:
- www.scopus.com
Diagnostics MDPI AG
Citações Recebidas na Web of Science: 18
Citações Recebidas na Scopus: 35
Documentos
- Não há documentos
Filiações
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
Citar a publicação
Sieverink CA,Batista RPM,Prazeres HJM,Vinagre J,Sampaio C,Leao RR,Máximo V,Witjes JA,Soares Dias Ferreira A. Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients. Diagn. 2020. 10. (10):p. 745-745. IF:3,706. (2).