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Actas Urológicas Españolas (English Edition) Diagnostic accuracy of Bladder EpiCheck for upper tract urothelial carcinoma: A ...
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Diagnostic accuracy of Bladder EpiCheck for upper tract urothelial carcinoma: A meta-analysis

Precisión de Bladder EpiCheck en el diagnóstico del carcinoma urotelial del tracto urinario superior: un metaanálisis
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1923
S. Artero Fullanaa,
Corresponding author
, J. Caño Velascoa,z,
Corresponding author
jorcavel@gmail.com

Corresponding author.
, A. Lafuente Puenteduraa, L. Polanco Pujola, V. Bataller Monforta, M. Moralejo Gáratea, J.D. Subielab, A. Galliolic, M. Moschinid, R. Pichlere, F. Del Giudicef, G. Marcqg, J. Teohh, F. Soriai, L. Mertensj, W. Krajewskik, E. Laukhtinal,m, K. Moril,n, B. Praderel,o, L. Afferip..., K.H. Tullyq, S. Albisinnir, Y. Abu Ghanems, D. d’Andreal, A. Marit, E. Albers Acostau, R. Contieriv, A. Cimadamorew, E. Grobet-Jeandinx, J. Gómez Rivasy, C. Hernández Fernándeza,z, en representación del Grupo de Trabajo de Carcinoma Urotelial de la Sección de Jóvenes Urólogos Académicos - Asociación Europea de Urología (EAU-YAU) Ver más
a Servicio de Urología, Hospital Universitario Gregorio Marañón, Madrid, Spain
b Servicio de Urología, Hospital Universitario Ramón y Cajal, IRYCIS, Universidad de Alcalá, Madrid, Spain
c Servicio de Urología, Fundación Puigvert, Universidad Autónoma de Barcelona, Barcelona, Spain
d División de Oncología Experimental, Servicio de Urología, Instituto de Investigación en Urología, Universidad Vita-Salute San Raffaele, Milán, Italy
e Servicio de Urología, Universidad Médica de, Innsbruck, Comprehensive Cancer Center Innsbruck (CCCI), Innsbruck, Austria
f Departmento de Ciencias Urológicas y Materno-Infantiles, Hospital Policlínico Umberto I, Universidad Sapienza de Roma, Roma, Italy
g Servicio de Urología, Hospital Claude Huriez, CHU Lille, Lille, France
h Departmento de Cirugía, Centro de Urología SH Ho, Universidad China de Hong Kong, Hong Kong, China
i División de Urología, Departamento de Ciencias Quirúrgicas, Facultad de Medicina de Turín, AOU Città della Salute e della Scienza di Torino, Turín, Italy
j Departamento de Urología, Netherlands Cancer Institute, Ámsterdam, Netherlands
k Departamento de Urología Robótica y Mínimamente Invasiva, Universidad de Medicina de Wrocław, Wrocław, Poland
l Departamento de Urología, Comprehensive Cancer Center, Universidad de Medicina de Viena, Viena, Austria
m Instituto de Urología y Salud Reproductiva, Universidad Sechenov, Moscú, Russia
n Departamento de Urología, Facultad de Medicina de la Universidad Jikei, Tokio, Japan
o Servicio de Urología, UROSUD, Hospital La Croix du Sud, Quint Fonsegrives, France
p Servicio de Urología, Luzerner Kantonsspital, Lucerna, Switzerland
q Servicio de Urología y Neurourología, Marien Hospital Herne, Universidad Ruhr de Bochum, Herne, Germany
r Unidad de Urología, Departamento de Ciencias Quirúrgicas, Hospital Universitario Tor Vergata, Universidad de Roma Tor Vergata, Roma, Italy
s The Specialist Centre for Kidney Cancer, Royal Free Hospital, Londres, United Kingdom
t Servicio de Urología, Hospital Careggi, Universidad de Florencia, Florencia, Italy
u Servicio de Urología, Hospital Universitario La Princesa, Madrid, Spain
v Servicio de Urología, Humanitas Clinical and Research Institute IRCCS, Milan, Italy
w Sección de Anatomía Patológica, Facultad de Medicina, Universidad Politécnica de la Región de Marcas, Ancona, Italy
x División de Urología, Hospitales Universitarios de Ginebra, Ginebra, Switzerland
y Servicio de Urología, Hospital Clínico San Carlos, Madrid, Spain
z Servicio de Urología, Hospital General Universitario Gregorio Marañón, Universidad Complutense de Madrid, Madrid, España
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Special issue
This article is part of special issue:
Urothelial Carcinoma: Updating the latest developments

Edited by: Andrea Gallioli Fundació Puigvert
Marco Moschini San Raffaele Hospital

Last update: June 2025

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Abstract
Introduction and objective

Current upper tract urothelial carcinoma (UTUC) diagnosis and disease management rely on the combination of CT Urography (CTU), cytology and ureteroscopy (URS). The limited accuracy and complications associated with these tools have led to the search for non-invasive and reliable biomarkers. Our aim was to review and analyse the existing data on the use of Bladder EpiCheck® to assess its performance as a diagnostic tool for UTUC.

Material and methods

A literature search on the diagnostic value of Bladder EpiCheck® as a urinary biomarker in UTUC was conducted through PubMed, Web of Science and Scopus until February 2024. Pooled sensitivity (Se), specificity (Sp), negative predictive value (NPV) and positive predictive value (PPV) of the biomarker were calculated. Diagnostic performance was assessed through the area under the curve (AUC).

Results

Four studies, including 334 patients, were included in the quantitative analysis. Bladder EpiCheck® showed promising pooled diagnostic values with Se of 0.85 (95% CI 0.55–0.96), Sp of 0.93 (95% CI 0.56–0.99), PPV of 0.74 (95% CI 0.54–0.87) and NPV of 0.84 (95% CI 0.77–0.89). The exact AUC obtained was 0.912.

Conclusions

Bladder EpiCheck® is an effective diagnostic tool in UTUC, showing a promising diagnostic accuracy, with a Se and NPV of 85% and 84%, respectively. Its use in UTUC diagnosis and follow-up could reduce or postpone the need for more invasive procedures, such as URS, thereby reducing the procedure-associated risks and improving patients’ quality of life. Although further research and large prospective studies are needed, the current results indicate that Bladder EpiCheck® is a promising tool in UTUC diagnosis, treatment decision-making, and follow-up.

Keywords:
Bladder EpiCheck
Upper tract urothelial carcinoma
UTUC
Urinary biomarker
DNA methylation
Resumen
Introducción y objetivo

El diagnóstico y el tratamiento del carcinoma urotelial del tracto superior (CUTS) actualmente se basan en la combinación de la urografía por tomografía computarizada (uro-TAC), la citología y la ureteroscopia (URS). La escasa precisión y las complicaciones asociadas a estas técnicas han motivado el desarrollo de biomarcadores más precisos y no invasivos. El objetivo de este estudio fue revisar y analizar los datos existentes sobre el uso de Bladder EpiCheck® para evaluar su rendimiento en el diagnóstico del CUTS.

Material y métodos

Se realizó una búsqueda bibliográfica sobre el valor diagnóstico de Bladder EpiCheck® como biomarcador urinario en el CUTS. Esta búsqueda se realizó en PubMed, Web of Science y Scopus hasta febrero de 2024. Se calcularon los valores agrupados de sensibilidad (S), especificidad (E), valor predictivo negativo (VPN) y valor predictivo positivo (VPP) del biomarcador. El rendimiento diagnóstico se evaluó mediante el área bajo la curva (ABC).

Resultados

En el análisis cuantitativo se incluyeron cuatro estudios con 334 pacientes. Bladder EpiCheck® mostró valores diagnósticos agrupados prometedores: S de 0,85(IC95% 0,55-0,96), E de 0,93(IC95% 0,56-0,99), VPP de 0,74(IC95% 0,54-0,87) y VPN de 0,84(IC95% 0,77-0,89). El valor exacto del ABC fue de 0,912.

Conclusiones

Bladder EpiCheck® es una herramienta diagnóstica eficaz en el estudio del CUTS, con una elevada precisión diagnóstica, una S y un VPN del 85% y el 84%, respectivamente. Su uso en el diagnóstico y seguimiento del CUTS podría reducir o posponer procedimientos más invasivos, como la URS, minimizando así los riesgos asociados al procedimiento y mejorando la calidad de vida de los pacientes. Aunque se necesitan más investigaciones y estudios prospectivos a gran escala, los resultados actuales indican que Bladder EpiCheck® es una herramienta prometedora para el diagnóstico, la elección del tratamiento y el seguimiento del CUTS.

Palabras clave:
Bladder EpiCheck
Carcinoma urotelial del tracto superior
CUTS
Biomarcador urinario
Metilación del ADN
Graphical abstract

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