Effect of a Single Instillation of Mitomycin C on the Intravesical Recurrence Rate After Ureteroscopy for Upper Tract Urothelial Carcinoma: A Prospective, Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Time to and total number of IVR after endoscopic vs radical treatment
研究概览
简要总结
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
详细描述
The primary objective is to evaluate the IVR rate after ureteroscopy (diagnostic or treatment) followed by an single instillation of MMC (SI-MMC), in patients with clinically non-metastatic UTUC.
The main question we aim 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
- 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.
Secondary objectives include the evaluation of possible predictive factors for IVR rate.
Study design: Multicentre, prospective cohort study in a clinical setting,
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Time to and total number of IVR after endoscopic vs radical treatment
时间窗: 2 years
What is the time to and total number of IVR after 2 years in patients who subsequently received treatment by endoscopy vs. radical nephroureterectomy
Time to and total number of Intravesical recurrences (IVR)
时间窗: 2 years
What is the time to and total number of IVR 2 years after ureteroscopy (diagnostic or treatment) with SI-MMC for UTUC
Time to and total IVR after diagnostic ureteroscopy in patients who received final treatment by RNU
时间窗: 2 years
Is there an additional value of SI-MMC on total and time to IVR after RNU in patients who were evaluated by ureteroscopy prior to RNU. Outcome measurement (time to IVR and total IVR) will be compared to a historical cohort who did not receive Mitomycin C to evaluate the additional effect
次要结局
- predictive factors for IVR(2 years)
研究者
Joyce Baard
drs J. Baard Urologist (PI)
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)