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Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test

Study acronym: UroDetect III
StatusNot Yet Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Study First Submitted
The goal of this clinical study is to learn how well a urine test called Xpert® Bladder Cancer Detect (Xpert BC-D) can help doctors assess the risk of bladder cancer in people with non-visible blood in their urine (microscopic hematuria). The main questions it aims to answer are: * Can the Xpert BC-D test accurately identify people at higher risk for bladder cancer? * Can combining the test results with other clinical information improve risk assessment compared to standard evaluation methods? Participants will: * Have leftover urine from the routine initial evaluation tested with the Xpert® Bladder Cancer Detect assay * Complete questionnaires about urinary symptoms using the modified IPSS and ICIQ-FLUT-S forms * Attend a first visit for medical evaluation and cystoscopy * Attend a follow-up visit 3 to 6 months later for additional testing and questionnaires This study includes adults over 40 years of age who have had microscopic hematuria detected within the past six months. People with a history of bladder cancer, urinary tract surgery, or certain other medical conditions, as well as individuals who are currently pregnant, cannot participate. The study will be conducted at 20-24 sites in Germany and Austria and will last approximately 27 months, with each participant involved for about 6 months. The results of this study may help doctors better decide which patients need further invasive testing, potentially reducing unnecessary procedures.
Trial Details
NCT Number NCT07307300
Lead Sponsor Christian Bolenz
Collaborators: Cepheid, Prof. Dr. med. Bernd Schmitz-Dräger
Conditions
(from sponsor)
Hematuria
Related terms Hematuria
Enrollment 1,475 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov