Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Hematuria. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)
Overview
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.
Primary outcome measures
- 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 [Time frame: From enrollment until completion of follow-up at 6 months]
Secondary outcome measures (7)
- Effective detection of high impact tumors (HITs, defined as Ta G3/HG, CIS, and ≥T1 urothelial cancer) [Time frame: From enrollment until completion of follow-up at 6 months]
- Validating results from a recent meta-analysis demonstrating improved risk stratification by combining the Xpert BC-D results with clinical parameters [Time frame: 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 [Time frame: From enrollment until completion of follow-up at 6 months]
- Cost-benefit considerations (based on structured information e.g. from GOÄ and EBM) [Time frame: 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) [Time frame: 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) [Time frame: 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 [Time frame: From enrollment until completion of follow-up at 6 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Urology and Pediatric Urology University Hospital Ulm — Ulm
Identifiers
NCT: NCT07307300 · UroDetect III