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Article

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

1
Department of Urology, Radboud University Nijmegen Medical Center, Geert Grooteplein Zuid 10, 6525 GA Nijmegen, The Netherlands
2
i3S-Instituto de Investigação e Inovação em Saúde, R. Alfredo Allen 208, 4200-135 Porto; Portugal
3
Instituto de Patologia e Imunologia Molecular da Universidade do Porto (IPATIMUP), Rua Júlio Amaral de Carvalho 45, 4200-135 Porto, Portugal
4
U-Monitor Lda, Rua Alfredo Allen, Nº 461 Paranhos, 4200-461 Porto, Portugal
5
Department of Pathology, Faculdade de Medicina, Universidade do Porto, Alameda Prof. Hernâni Monteiro, 4200-319 Porto, Portugal
6
Department of Urology, Hospital de Braga, Sete Fontes—São Victor, 4710-243 Braga, Portugal
7
Department of Urology, Hospital CUF Coimbra, Rua Camilo Pessanha 1, 3000-600 Coimbra, Portugal
8
Faculdade de Medicina de Coimbra (FMUC), Rua Larga 2, 3000-370 Coimbra, Portugal
*
Author to whom correspondence should be addressed.
These authors contributed equally to this work.
Diagnostics 2020, 10(10), 745; https://doi.org/10.3390/diagnostics10100745
Received: 14 August 2020 / Revised: 14 September 2020 / Accepted: 22 September 2020 / Published: 24 September 2020
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® 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®’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® 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® revealed promising properties for the follow-up of patients with NMIBC. View Full-Text
Keywords: biomarkers; bladder cancer; cystoscopy; cytology; follow-up; non-muscle-invasive bladder cancer; recurrence; urine test biomarkers; bladder cancer; cystoscopy; cytology; follow-up; non-muscle-invasive bladder cancer; recurrence; urine test
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MDPI and ACS Style

Sieverink, C.A.; Batista, R.P.M.; Prazeres, H.J.M.; Vinagre, J.; Sampaio, C.; Leão, R.R.; Máximo, V.; Witjes, J.A.; Soares, P. Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients. Diagnostics 2020, 10, 745. https://doi.org/10.3390/diagnostics10100745

AMA Style

Sieverink CA, Batista RPM, Prazeres HJM, Vinagre J, Sampaio C, Leão RR, Máximo V, Witjes JA, Soares P. Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients. Diagnostics. 2020; 10(10):745. https://doi.org/10.3390/diagnostics10100745

Chicago/Turabian Style

Sieverink, Caroline A., Rui P.M. Batista, Hugo J.M. Prazeres, João Vinagre, Cristina Sampaio, Ricardo R. Leão, Valdemar Máximo, J. A. Witjes, and Paula Soares. 2020. "Clinical Validation of a Urine Test (Uromonitor-V2®) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients" Diagnostics 10, no. 10: 745. https://doi.org/10.3390/diagnostics10100745

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