Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC

Recruiting now

Conditions studied: Upper Urinary Tract Carcinoma

In brief

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

Key facts

Study ID: NCT05731622
Run by: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
People needed: 100
Starts: 2024-02-01
Expected to finish: 2026-09-01
Last updated by the study team: 2024-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

AmsterdamUMC — Amsterdam, Netherlands (enrolling)

Full record on ClinicalTrials.gov

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