Hematuria
Conditions
Keywords
Non-visible hematuria, Microscopic hematuria, Bladder cancer risk, Xpert Bladder Cancer Detect, Risk stratification, Diagnostic assessment, Urinary marker
Brief 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.
Interventions
None listed
Sponsors
Cepheid
Prof. Dr. med. Bernd Schmitz-Dräger
Christian Bolenz
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | From enrollment until completion of follow-up at 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Validating results from a recent meta-analysis demonstrating improved risk stratification by combining the Xpert BC-D results with clinical parameters | From enrollment until completion of follow-up at 6 months |
| 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 | From enrollment until completion of follow-up at 6 months |
| Cost-benefit considerations (based on structured information e.g. from GOÄ and EBM) | From enrollment until completion of follow-up at 6 months |
| Effective detection of high impact tumors (HITs, defined as Ta G3/HG, CIS, and ≥T1 urothelial cancer) | From enrollment until completion of follow-up at 6 months |
| Prospective assessment of symptoms of nvH patients (assessment using modified versions of ICIQ-FLUTS and IPSS) | From enrollment until completion of follow-up at 6 months |
| Investigating the frequency of conditions requiring medical and/or surgical intervention resulting from nvH assessment | From enrollment until completion of follow-up at 6 months |
| Investigating the rate of negative TUR-Bs triggered by standard-of-care (SOC) vs. positive findings by Xpert BC-D results and respective combination with clinical results. (study not powered for confirmation of a significant difference) | From enrollment until completion of follow-up at 6 months |
Countries
Germany
Contacts
Primary ContactChristian Bolenz, Univ. Prof. Dr. med.
Outcome results
None listed