Clinical trial · Interventional
Surveillance of High-grade Non-muscle Invasive Bladder Tumours Using the Xpert Bladder Cancer Monitor
NCT04100733CI-TRIAL-00066854SEALS Xpertactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The study aims to evaluate the potential clinical impact of a highly sensitive urinary marker, the Xpert Bladder Cancer Monitor, regarding possible reduction in number of flexible cystoscopies in an outpatient setting without decreasing recurrence-free survival or increasing risk of progression.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-muscle Invasive Bladder Cancer | — | UNRESOLVED | — |
| Urinary Biomarker | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Flexible cystoscopy (WL/NBI) and urinary cytology | Diagnostic Test | — | UNRESOLVED |
| Xpert Bladder Cancer Monitor | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Study subjects will cohere to current clinical guidelines for follow-up regimes of HG NMIBC with flexible cystoscopy and cytology every four months for a period of two years.
- interventionNames
- Diagnostic Test: Flexible cystoscopy (WL/NBI) and urinary cytology
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Patients in the interventional arm will be followed at 4, 8, 16 and 20 months after inclusion with Xpert Bladder Cancer Monitor-test (and urinary cytology) instead of flexible cystoscopy.
- interventionNames
- Diagnostic Test: Xpert Bladder Cancer Monitor
Primary outcomes (1)
- measure
- Recurrence-free survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years of age at the time of signing the Informed Consent Form * Ability to understand the Participant Information sheet orally and in writing * Signed Informed Consent Form * Is, according to the investigator's judgement, able to comply with the trial protocol * Previously diagnosed with high grade NMIBC Recurrence free at the time of inclusion detected by flexible cystoscopy Exclusion Criteria: * History of any upper urinary tract tumor regardless of grade and stage within the last 5 years prior to randomization * T1 tumor where re-resection has not been performed * CIS or invasive tumor within 3 months before randomization
References
Publications (0)
Data not yet available
No reference posted for this study.