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

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Validating results of a recent metanalysis (UroDetect II) achieving an overall sensitivity of the Xpert BC-D for UCas of >0.70 and a specificity of >0.65 — From enrollment until completion of follow-up at 6 months

Trial sites (1)