Evaluating the recurrence of upper urinary tract cancer after ureteroscopy and Mitomycin C treatment
Effect of a Single Instillation of Mitomycin C on the Intravesical Recurrence Rate After Ureteroscopy for Upper Tract Urothelial Carcinoma: A Prospective, Multicenter Study
This study is testing if a single treatment with Mitomycin C after ureteroscopy can help prevent the return of upper urinary tract cancer in patients over two years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT05731622 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the rate of intravesical recurrence (IVR) following ureteroscopy for upper tract urothelial carcinoma (UTUC) in patients who receive a single instillation of Mitomycin C (SI-MMC). It will track the total and time to IVR over a two-year period and compare these outcomes with a historical cohort that did not receive SI-MMC. Additionally, the study will evaluate the effectiveness of SI-MMC in patients who undergo further treatment, such as endoscopy or radical nephroureterectomy. The study will also explore predictive factors for IVR rates.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a suspicion of non-metastatic upper urinary tract urothelial carcinoma who are scheduled for ureteroscopy and SI-MMC.
Not a fit: Patients with a history of bladder cancer, concurrent bladder tumors, or those who cannot undergo histological evaluation during the procedure may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into improving treatment outcomes and reducing recurrence rates for patients with upper urinary tract carcinoma.
How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in reducing recurrence rates with Mitomycin C in other settings.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Amsterdam
- AmsterdamUMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Joyce Baard, MD, MSc — AmsterdamUMC
- Study coordinator: Joyce Baard, MD, MSc
- Email: j.baard@amsterdamumc.nl
- Phone: +31 020 444 0261
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.