HematuriaUroDetect IIINCT07307300
Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test
An observational study of Hematuria, run by Christian Bolenz at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Hematuria
- How many people
- 1,475 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2026to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
Urology and Pediatric Urology University Hospital Ulm
Ulm, 89081
Christian Bolenz, Univ. Prof. Dr. med., +49 731 500 58000, studien.urologie@uniklinik-ulm.de
Christian Bolenz, Univ. Prof. Dr. med.
About this study
Official title: Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)
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?
Read more
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
- Hematuria
- Keywords
- Non-visible hematuria, Microscopic hematuria, Bladder cancer risk, Xpert Bladder Cancer Detect, Risk stratification, Diagnostic assessment, Urinary marker
- Medical subject headings
- Hematuria
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment until completion of follow-up at 6 months
Secondary outcomes (7)
Effective detection of high impact tumors (HITs, defined as Ta G3/HG, CIS, and ≥T1 urothelial cancer)
Measured: 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
Measured: 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
Measured: From enrollment until completion of follow-up at 6 months
Cost-benefit considerations (based on structured information e.g. from GOÄ and EBM)
Measured: 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)
Measured: 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)
Measured: 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
Measured: From enrollment until completion of follow-up at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study startMar 2026 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HematuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,475 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Christian Bolenz
- Sponsor type
- University, hospital or other
- Collaborators
- Cepheid, Prof. Dr. med. Bernd Schmitz-Dräger
- Responsible party
- Sponsor-investigator, Christian Bolenz, University Hospital Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307300
- Sponsor's protocol ID
- UroDetect III
- Acronym
- UroDetect III
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified participant data may be shared upon reasonable request with qualified researchers after publication of the main study results
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification of Patients With Non-Visible Hematuria - A Prospective Validation Study Using a Urine Marker-Based Assessment (Xpert® Bladder Cancer Detect)
- ClinicalTrials.gov ID
- NCT07307300
- Acronym / sponsor ID
- UroDetect III / UroDetect III
- Conditions
- Hematuria
- Keywords
- Non-visible hematuria, Microscopic hematuria, Bladder cancer risk, Xpert Bladder Cancer Detect, Risk stratification, Diagnostic assessment, Urinary marker
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,475 participants (estimated)
- Lead sponsor
- Christian BolenzUniversity, hospital or other
- Collaborators
- Cepheid, Prof. Dr. med. Bernd Schmitz-Dräger
- Study start
- Mar 2026 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (15 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified participant data may be shared upon reasonable request with qualified researchers after publication of the main study results
Related trials for Hematuria
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UTUC, UC (Urothelial Cancer)
Not yet recruitingPhase 3
Effectiveness of Medical and Environmental Interventions to Reduce Cystoscopy Discomfort (CystoDiscomfort)
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Hematuria - Cause Not Known
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematuria, run by Christian Bolenz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Bolenz, Univ. Prof. Dr. med. (+49 731 500 58000, PM.ZKS@uniklinik-ulm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: From enrollment until completion of follow-up at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.