Clinical trial · Observational
Validation Study of Uromonitor in High Risk Microhematuria Patients
Estudio de validación de Uromonitor en el diagnóstico Precoz de cáncer Vesical en Pacientes de Alto Riesgo Con Microhematuria
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Men over 40 years of age, and women over 50, smokers or former smokers with a smoking rate greater than 10 packs/year and the presence of microhematuria \>25 red blood cells per field in the microscopic analysis are at high risk of bladder cancer, so cystoscopy and uroTAC is advised in the AUA Guidelines. The investigators hypothesize if cystoscopy can be omitted in case of having a negative biomarker test and a normal uro-CT. Main objective: To determine sensitivity, specificity, positive and negative predictive value of "Uromonitor" (molecular DNA based urine marker) in the included population, in relation to the presence of urothelial cancer in the bladder, comparing it with cystoscopy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Accuracy of Uromonitor in diagnosis of bladder cancer in high risk micro hematuria
- timeFrame
- 18 months
- description
- Specificity, sensibility, negative and positive predictive value of Uromonitor in high risk microhematuria patients
Secondary outcomes (1)
- measure
- acuracy of Uromonitor in diagnosis of high grade bladder tumours in this population
- timeFrame
- 18 months
- description
- Sensibility of uromonitor in detecting high grade bladder tumours
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria (all conditions must be certified): * Men over 40 years of age or Women over 50 years of age. * Smokers or former smokers * Smoking rate \>10 packs/year * Microhematuria with \>25 red blood cells per hpf. Exclusion Criteria: (any of them): * Patients who refuse to undergo cystoscopy. * Patients who refuse or cannot perform imaging tests of the upper section due to allergy or chronic kidney disease. * History of macroscopic hematuria. * History of microscopic hematuria already known and studied. * Known cause of microhematuria: e.g. urinary infection, bladder lithiasis * Patients who refuse to participate in the study.
References
Publications (3)
- BACKGROUNDBarocas DA, Boorjian SA, Alvarez RD, Downs TM, Gross CP, Hamilton BD, Kobashi KC, Lipman RR, Lotan Y, Ng CK, Nielsen ME, Peterson AC, Raman JD, Smith-Bindman R, Souter LH. Microhematuria: AUA/SUFU Guideline. J Urol. 2020 Oct;204(4):778-786. doi: 10.1097/JU.0000000000001297. Epub 2020 Jul 23. PMID 32698717
- BACKGROUNDLaukhtina E, Shim SR, Mori K, D'Andrea D, Soria F, Rajwa P, Mostafaei H, Comperat E, Cimadamore A, Moschini M, Teoh JY, Enikeev D, Xylinas E, Lotan Y, Palou J, Gontero P, Babjuk M, Witjes JA, Kamat AM, Roupret M, Shariat SF, Pradere B; European Association of Urology-Young Academic Urologists (EAU-YAU): Urothelial Carcinoma Working Group. Diagnostic Accuracy of Novel Urinary Biomarker Tests in Non-muscle-invasive Bladder Cancer: A Systematic Review and Network Meta-analysis. Eur Urol Oncol. 2021 Dec;4(6):927-942. doi: 10.1016/j.euo.2021.10.003. Epub 2021 Nov 6. PMID 34753702
- BACKGROUNDSieverink CA, Batista RPM, Prazeres HJM, Vinagre J, Sampaio C, Leao RR, Maximo V, Witjes JA, Soares P. Clinical Validation of a Urine Test (Uromonitor-V2(R)) for the Surveillance of Non-Muscle-Invasive Bladder Cancer Patients. Diagnostics (Basel). 2020 Sep 24;10(10):745. doi: 10.3390/diagnostics10100745. PMID 32987933