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Validation Study of Uromonitor in High Risk Microhematuria Patients

NCT05344937 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 343

Last updated 2022-05-02

No results posted yet for this study

Summary

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

Sponsors & Collaborators

  • IPATIMUP - Instituto De Patologia E Imunologia Molecular Da Universidade Do Porto

    collaborator OTHER

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Principal Investigators

  • Felipe Villacampa, MD · Clinica Universidad de Navarra

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-02
Primary Completion
2023-12-31
Completion
2024-05-01

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05344937 on ClinicalTrials.gov