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.
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
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
Adults over 40 years with non-visible blood in the urine. Participants are either initially identified by referring primary care physicians and further evaluated at the study sites for possible inclusion, or they are directly identified at the study sites during routine evaluation when microhematuria is detected. Recruitment takes place at multiple urology clinics in Germany and Austria.
Cohort
Prospective
Not listed
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
Effective detection of high impact tumors (HITs, defined as Ta G3/HG, CIS, and ≥T1 urothelial cancer)
Validating results from a recent meta-analysis demonstrating improved risk stratification by combining the Xpert BC-D results with clinical parameters
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
Cost-benefit considerations (based on structured information e.g. from GOÄ and EBM)
Click on the lead sponsor to view all of their trials.
Christian Bolenz
Lead sponsor
University Hospital Ulm
Sponsor institution
Cepheid
Collaborator
Prof. Dr. med. Bernd Schmitz-Dräger
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
