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Not Yet Recruiting NCT05731622

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

Conditions: Upper Urinary Tract Carcinoma

Sex: All
Ages: 18 Years – N/A
Enrollment: 100
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Summary

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 UTUCHow 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

Eligibility Criteria

Inclusion Criteria:All patients suspect for having non-metastatic disease and planned for ureteroscopy (diagnostic or treatment) and adjuvant single instillation of Mitomycin CAge ≥18 yearsWritten informed consentExclusion Criteria:History of histological proven urothelial carcinoma of the bladder, including carcinoma in situHistory of histological proven UTUC in the contralateral kidneyConcurrent bladder tumour found pre-operatively or per-operativelyPatients where it is not feasible to obtain histology by biopsies intra-operativelyKnown Mitomycin CRenal transplantation

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05731622). StuddyBuddy aggregates publicly available trial information.