Clinical trial · Observational
Urine-based Detection of Non-muscle Invasive Bladder
Urine-based Detection of Non-muscle Invasive Bladder Cancer Recurrence
- 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)
Non-muscle invasive bladder cancer (NMIBC), which comprises approximately 75% of bladder tumors, has the highest recurrence rate of all cancers, with around 70% of the patients developing local recurrences, despite elaborated treatments. Uromonitor is a completely Non-Invasive urine based IVD diagnosis test. It´s able to detect Non-muscle invasive bladder cancer with 100% sensitivity and 97,3 % specificity. Regardless of Tumor stage and grade (unlike Cytology). The rate of Uromonitor false positives (2,3%) is actually lower than the rate of Cystoscopy false positives (3,5%).
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 (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Flexcystoscopy/Uromonitor
- description
- Control cystoscopy every 4 - 8 and 12 months as a standard procedure, And Urine test (Uromonitor) every 4 months
Primary outcomes (1)
- measure
- Recurrences rate
- timeFrame
- 5 years
- description
- Recurrences rate
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients who previously had low grad NMIBC. * Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up. Exclusion Criteria: * Clinical suspicion of muscle invasive bladder cancer * Upper urinary track tumours * Patients undergoing neoadjuvant chemotherapy based on local protocols * Metastatic urothelial carcinoma * Patients recived installation therapy within the last 4 weeks
References
Publications (0)
Data not yet available