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

NCT07307300 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1475

Last updated 2025-12-29

No results posted yet for this 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.

Conditions

  • Hematuria

Sponsors & Collaborators

  • Cepheid

    collaborator INDUSTRY

  • Prof. Dr. med. Bernd Schmitz-Dräger

    collaborator UNKNOWN

  • Christian Bolenz

    lead OTHER

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2028-06-30
Completion
2028-06-30

Countries

  • Germany

Study Locations

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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 NCT07307300 on ClinicalTrials.gov