Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test
NCT ID: NCT07307300
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
1475 participants
OBSERVATIONAL
2026-03-31
2028-06-30
Brief Summary
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* 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.
Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Willing and able to follow the study requirements
* Non-visible blood in the urine, found within the past 6 months
* Age over 40 years
Exclusion Criteria
* Too much protein in the urine (shown by urine test)
* Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test)
* Current pain in the urinary tract or lower belly, pain score greater than 2 on a 0-10 scale
* Signs of kidney-related blood in the urine (found by special urine test)
* Bladder examination with a camera (cystoscopy) within the past 12 months
* Pregnancy
* Visible blood in the urine within the past year
* Previous surgery on the urinary tract
* Previous radiation treatment to the pelvic area
* Permanent tube or foreign body in the urinary tract (such as a catheter)
* Participation in another clinical study at the same time or within 30 days before this study
* Detained under legal or official authority
* Medical, psychological, or social problems that would make it hard to follow the study requirements
* Not able to understand the study information well enough to give consent
40 Years
ALL
No
Sponsors
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Cepheid
INDUSTRY
Prof. Dr. med. Bernd Schmitz-Dräger
UNKNOWN
Christian Bolenz
OTHER
Responsible Party
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Christian Bolenz
Prof. Dr. med. Christian Bolenz
Locations
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Urology and Pediatric Urology University Hospital Ulm
Ulm, , Germany
Countries
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Central Contacts
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Christian Bolenz, Univ. Prof. Dr. med.
Role: CONTACT
Phone: +49 731 500 58000
Email: [email protected]
Facility Contacts
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Christian Bolenz, Univ. Prof. Dr. med.
Role: primary
Other Identifiers
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UroDetect III
Identifier Type: -
Identifier Source: org_study_id