Urine test to assess bladder cancer risk in people with blood in urine
Tests a urine marker in adults over 40 with non-visible blood in urine.
Plain-language title generated from the registry record
Registry title: Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test
Key facts
- Where
- Ulm, GermanySee the site
Where in Germany
- Urology and Pediatric Urology University Hospital UlmUlm, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Christian Bolenz
- Trial code
- NCT07307300
- Record updated
- 29 December 2025
- Original description
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:Read full original descriptionShow less
Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)
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.
Inclusion: Signed consent form after being informed about the study; 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: Previous diagnosis of bladder cancer; Previous surgery on the urinary tract; Previous radiation treatment to the pelvic area; Participation in another clinical study at the same time or within 30 days before this study; Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test); Too much protein in the urine (shown by 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; Permanent tube or foreign body in the urinary tract (such as a catheter); 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.