Clinical trial · Observational
Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC
Effect of a Single Instillation of Mitomycin C on the Intravesical Recurrence Rate After Ureteroscopy for Upper Tract Urothelial Carcinoma: A Prospective, Multicenter 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)
The goal of this observational study is to evaluate the intravesical recurrence (IVR) rate after ureteroscopy (diagnostic or treatment) for upper tract urothelial carcinoma (UTUC) followed by an adjuvant single instillation of Mitomycin C (SI-MMC). The main question it aims to answer are: * What is the total and time to IVR after 2 years after ureteroscopy (diagnostic or treatment) for UTUC * How is the IVR compared with a historical cohort (no SI-MMC) * What is the time to IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy (RNU) * What is the additional value of a SI-MMC on time to IVR after RNU + adjuvant MMC in patients who were evaluated by ureteroscopy prior to RNU
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 |
|---|---|---|---|
| Upper Urinary Tract Carcinoma | Renal Pelvis and Ureter Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (3)
- measure
- Time to and total number of Intravesical recurrences (IVR)
- timeFrame
- 2 years
- description
- What is the time to and total number of IVR 2 years after ureteroscopy (diagnostic or treatment) with SI-MMC for UTUC
- measure
- Time to and total number of IVR after endoscopic vs radical treatment
- timeFrame
- 2 years
- description
- What is the time to and total number of IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy
- measure
- Time to and total IVR after diagnostic ureteroscopy in patients who received final treatment by RNU
- timeFrame
- 2 years
- description
- Is there an additional value of SI-MMC on total and time to IVR after RNU in patients who were evaluated by ureteroscopy prior to RNU. Outcome measurement (time to IVR and total IVR) will be compared to a historical cohort who did not receive Mitomycin C to evaluate the additional effect
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All patients suspect for having non-metastatic disease and planned for ureteroscopy (diagnostic or treatment) and adjuvant single instillation of Mitomycin C * Age ≥18 years * Written informed consent Exclusion Criteria: * History of histological proven urothelial carcinoma of the bladder, including carcinoma in situ * History of histological proven UTUC in the contralateral kidney * Concurrent bladder tumour found pre-operatively or per-operatively * Patients where it is not feasible to obtain histology by biopsies intra-operatively * Known Mitomycin C * Renal transplantation
References
Publications (0)
Data not yet available