Clinical trial · Observational
UroX Biomarker Bladder Cancer Study
Evaluation of UroX™ Biomarker Screening Test in the Investigation of Bladder Cancer From Urine Samples - a Single Site Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective observational study looking at urine samples from participants under referral for a standard of care investigative cystoscopy and biopsy. The study aims to test if the UroX™ biomarker (a measurable indicator of a biological condition) can be detected in urine samples from participants who may later test positive following a biopsy for bladder cancer. The study aims to assess the value of the biomarker as a screening tool for bladder cancer. Patients with and those without bladder cancer are required for the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| UroX bladder cancer biomarker test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Participants with bladder cancer
- description
- 50 participants with histologically confirmed evidence of malignancy for bladder cancer following routine cystoscopy and biopsy.
- interventionNames
- Diagnostic Test: UroX bladder cancer biomarker test
- label
- Participants without bladder cancer
- description
- 50 participants with negative biopsy for bladder cancer following routine cystoscopy and biopsy.
- interventionNames
- Diagnostic Test: UroX bladder cancer biomarker test
Primary outcomes (1)
- measure
- Evaluate the diagnostic accuracy of the UroX™ biomarker urine test
- timeFrame
- 1 day (single visit/test)
- description
- UroX™ urine biomarker staining result compared with standard of care biopsy result
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged ≥ 18 years of age * Patients under investigation for bladder cancer due to undergo investigative standard of care biopsy Exclusion Criteria: * Patients aged \< 18 years of age * Patients who are currently undergoing radiation therapy. * Proposed subject has no bladder (due to surgical removal). * No cystoscopy and/or pathology information for proposed subject (following cystoscopy for final inclusion in study results) * Patients unable or unwilling to provide consent * Patients currently on investigational drug trials * Patients with Catheter in Situ
References
Publications (0)
Data not yet available