Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hematuria | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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
- timeFrame
- From enrollment until completion of follow-up at 6 months
Secondary outcomes (7)
- measure
- Effective detection of high impact tumors (HITs, defined as Ta G3/HG, CIS, and ≥T1 urothelial cancer)
- timeFrame
- From enrollment until completion of follow-up at 6 months
- measure
- Validating results from a recent meta-analysis demonstrating improved risk stratification by combining the Xpert BC-D results with clinical parameters
- timeFrame
- From enrollment until completion of follow-up at 6 months
- measure
- Simulating application of current major guideline recommendations, a significantly better discrimination between patients at low/high risk for subsequent UCa diagnosis for: The Xpert BC-D results and combinations from Xpert BC-D results and clinical
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Previous diagnosis of bladder cancer * 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
References
Publications (0)
Data not yet available