NCT07307300Not yet recruiting
Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test
Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)
Source: ClinicalTrials.gov · Last updated 29 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 1475 (estimated)
- First submitted
- 14 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- Jun 2028
- Lead sponsor
- Christian Bolenz
- Diseases
- Bladder cancer
- NCT number
- NCT07307300
What you commit to
- Study type: Observational
- Planned participants: 1475
- From Mar 2026 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Current urinary tract infection (symptoms like pain or frequent urination, plus bacteria found in urine test)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 40 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urology and Pediatric Urology University Hospital Ulm Coordinator of this site? Confirm its status | Ulm | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.