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

NCT07307300 | Not Yet Recruiting

• 1 other identifier: UroDetect III
• Study Type: observational
• Target: 1,475
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematuria

Keywords

Non-visible hematuria; Microscopic hematuria; Bladder cancer risk; Xpert Bladder Cancer Detect; Risk stratification; Diagnostic assessment; Urinary marker

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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

• 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

• 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

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christian Bolenz: lead
• Cepheid: collaborator
• Prof. Dr. med. Bernd Schmitz-Dräger: collaborator

Study Sites (1)

Urology and Pediatric Urology University Hospital Ulm

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Hematuria

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christian Bolenz, Univ. Prof. Dr. med.

CONTACT

+49 731 500 58000; PM.ZKS@uniklinik-ulm.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Christian Bolenz

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: December 29, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Available from 6 months after publication of the main study results for a period of 5 years.
• 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.

Locations

DE (1)