Study on Risk Assessment for Patients With Microscopic Hematuria (Non-Visible Blood in Urine) Using a Urine Marker Test (UroDetect III)

December 14, 2025 updated by: Christian Bolenz

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?

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1475

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Germany
      • Ulm, Germany, 89081
        • Urology and Pediatric Urology University Hospital Ulm
        • Contact:
        • Principal Investigator:
          • Christian Bolenz, Univ. Prof. Dr. med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome 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
Time Frame: From enrollment until completion of follow-up at 6 months
From enrollment until completion of follow-up at 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
From enrollment until completion of follow-up at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Christian Bolenz

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cepheid
Prof. Dr. med. Bernd Schmitz-Dräger

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 14, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UroDetect III

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified participant data may be shared upon reasonable request with qualified researchers after publication of the main study results

IPD Sharing Time Frame

Available from 6 months after publication of the main study results for a period of 5 years.

IPD Sharing Access Criteria

Access to individual participant data (IPD) and supporting information will be granted upon reasonable request. Qualified researchers with a methodologically sound proposal and a clear scientific rationale will be eligible to apply for access.

Approval for data access will be granted by the Sponsor-Investigator in coordination with the Data Protection Officer of the affiliated organization (UHUlm) and, if applicable, in consultation with the responsible Ethics Committee. Requests will be evaluated according to predefined criteria for scientific merit, data protection, and regulatory compliance (e.g., GDPR).

Approved applicants will be required to sign a Data Use Agreement (DUA) specifying conditions of use, including restrictions on re-identification, redistribution, and secondary use outside the agreed scope. All shared data will be de-identified and will be provided via a secure, controlled-access repository or through secure file transfer, depending on feasibility.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hematuria

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings