NCT05731622 Effect of a SI-MMC on the IVR Rate After Ureteroscopy for UTUC
| NCT ID | NCT05731622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Upper Urinary Tract Carcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-02 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
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 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
Contact & Investigator
Joyce Baard, MD, MSc
PRINCIPAL INVESTIGATOR
AmsterdamUMC
Frequently Asked Questions
Who can join the NCT05731622 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Upper Urinary Tract Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05731622 currently recruiting?
Yes, NCT05731622 is actively recruiting participants. Contact the research team at j.baard@amsterdamumc.nl for enrollment information.
Where is the NCT05731622 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05731622 clinical trial?
NCT05731622 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Joyce Baard, MD, MSc at AmsterdamUMC. The trial plans to enroll 100 participants.