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

Study acronym: SINCERE
StatusUnknown
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 31, 2024 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Jan 2024); last known: Recruiting
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Feb 2023 to Feb 2024 · Study sites: 0 to 1v2 Show 2 more changesShow less
    • Start date: Feb 2023 to Feb 2024
    • Study sites: 0 to 1
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT05731622
Lead Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions Upper Urinary Tract Carcinoma
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov