000163969 001__ 163969
000163969 005__ 20251113160753.0
000163969 0247_ $$2doi$$a10.1111/bju.70010
000163969 0248_ $$2sideral$$a146093
000163969 037__ $$aART-2025-146093
000163969 041__ $$aeng
000163969 100__ $$aRubio-Briones, José
000163969 245__ $$aExternal validation of the Uromonitor®-version 2 urine test as a biomarker for optimisation of non-muscle-invasive bladder cancer management
000163969 260__ $$c2025
000163969 5203_ $$aObjectives
To conduct an external multicentre validation to evaluate Uromonitor®‐version 2 (v2; U‐monitor, Porto, Portugal) as a biomarker for detecting non‐muscle‐invasive bladder cancer (NMIBC) recurrence in an independent patient cohort in a real‐world‐evidence setting and compare it to cytology.
Patients and Methods
The ‘External Validation of Uromonitor as a Biomarker for Optimization of NMIBC Management by the Club Urológico Español de Tratamiento Oncológico Group’ (EVALUATION‐CUETO) study is a prospective, multicentre, observational study (NCT05864599) conducted in Spain. Inclusion criteria included any risk group of patients with NMIBC undergoing follow‐up. The most recent (index) NMIBC tumours of any grade had to have been diagnosed within the past 3 months to 2 years. Regarding biomarkers, data from cystoscopy, cytology, and the Uromonitor‐v2 test were collected. Predictive performance parameters, including accuracy, area under the curve, negative and positive predictive values (NPV, PPV), sensitivity, and specificity, were calculated.
Results
A total of 1178 patients with a mean age of 72 years and a predominant male representation (80%) were included. Among the positive Uromonitor-v2 cases, 64 (57.66%) exhibited a TERT promoter mutation, and 59 (53.15%) harboured a FGFR3 mutation. No KRAS mutations were found. For the total population, Uromonitor-v2 demonstrated high specificity (0.93) and NPV (0.93), but low sensitivity (0.36) and PPV (0.36), indicating a limited ability to detect all recurrences and confirm positive cases. Performance varied across tumour grades, with low-grade tumours showing a low sensitivity of 0.32 and high-grade tumours achieving a higher but insufficient sensitivity of 0.44. Specificity remained consistent at 0.93 across all groups. Uromonitor-v2 achieved higher accuracy compared to cytology alone, with the combined approach further improving overall predictive performance.
Conclusion
The strong specificity and NPV observed across all studies suggest a role of Uromonitor‐v2 as a potential tool for NMIBC follow‐up, particularly in ruling out recurrence and clarifying doubtful cystoscopy results. However, the unexpectedly low sensitivity reported in this external multicentre validation suggests the need for further investigation before routine clinical implementation.
000163969 540__ $$9info:eu-repo/semantics/closedAccess$$aAll rights reserved$$uhttp://www.europeana.eu/rights/rr-f/
000163969 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion
000163969 700__ $$aGuerrero Ramos, Félix
000163969 700__ $$aMercadé Sánchez, Asier
000163969 700__ $$aBezana Abadía, Inés
000163969 700__ $$aMartín Rodríguez, Ruth
000163969 700__ $$aAlcaraz, Antonio
000163969 700__ $$aMiqueleiz Legaz, Maite
000163969 700__ $$aLozano, Fernando
000163969 700__ $$aArrabal Martín, Miguel
000163969 700__ $$aLuis Cardo, Adrián
000163969 700__ $$aGonzalo Rodríguez, Victoria
000163969 700__ $$aCaño Velasco, Jorge
000163969 700__ $$aSerrano Liesa, Miriam
000163969 700__ $$aFerreiro Pareja, Cristina
000163969 700__ $$aEspílez Ortiz, Raquel$$uUniversidad de Zaragoza
000163969 700__ $$aGonzález-Valcárcel de Torres, Ignacio de
000163969 700__ $$aSánchez Zalabardo, Daniel
000163969 700__ $$aEsquinas, Cristina
000163969 700__ $$aMengual, Lourdes
000163969 700__ $$0(orcid)0000-0003-0178-4567$$aBorque-Fernando, Angel$$uUniversidad de Zaragoza
000163969 700__ $$0(orcid)0000-0002-3007-302X$$aEsteban Escaño, Luis Mariano
000163969 700__ $$aPalou Redorta, Joan
000163969 700__ $$aWitjes, Fred
000163969 700__ $$aMartínez Piñeiro, Luis
000163969 7102_ $$11013$$2817$$aUniversidad de Zaragoza$$bDpto. Cirugía$$cÁrea Urología
000163969 773__ $$g(2025), [9 p.]$$pBJU int.$$tBJU international$$x1464-4096
000163969 8564_ $$s630512$$uhttps://zaguan.unizar.es/record/163969/files/texto_completo.pdf$$yVersión publicada$$zinfo:eu-repo/date/embargoEnd/2026-10-01
000163969 8564_ $$s2795403$$uhttps://zaguan.unizar.es/record/163969/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada$$zinfo:eu-repo/date/embargoEnd/2026-10-01
000163969 909CO $$ooai:zaguan.unizar.es:163969$$particulos$$pdriver
000163969 951__ $$a2025-11-13-14:58:47
000163969 980__ $$aARTICLE