Estudio de validación de Uromonitor en el diagnóstico Precoz de cáncer Vesical en Pacientes de Alto Riesgo Con Microhematuria

1. Title: Validation study of Uromonitor in the early diagnosis of bladder cancer in high-risk patients with microhematuria. Version: 2.0. March 6, 2022.

Main author: Felipe Villacampa Aubá. Department of Urology, University Clinic of Navarra (CUN). 2. Justification and context. Patients with microhematuria and smokers have a high risk of having bladder cancer (5-10%), so a cystoscopy and Urotac should be performed.

Cystoscopy is an uncomfortable test, which is rejected by many patients. The aim is to assess whether a urine molecular marker, already validated in other situations, is capable of substituting cystoscopy, improving the study of these patients and avoiding uncomfortable and invasive diagnostic tests for the patient. 3. Hypotheses and research objectives. Hypothesis: Men over 40 years of age, and women over 50, smokers or ex-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 (high risk) can omit cystoscopy 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" in the included population, in relation to the presence of urothelial cancer in the bladder, comparing it with cystoscopy. 4. Study design. This is a prospective observational study, in which the results of the "Uromonitor" test in urine are compared with the results of cystoscopy, a standard test in the population studied, to be able to detect urothelial cancer in the bladder.

Patients seen at the University Clinic of Navarra by the Neurology Department (Pamplona and Madrid) with microhaematuria of more than 25 red blood cells per field will be included, being referred to urology department to study the risk of bladder cancer.