NCT05874921招募中不适用
uTRACT Jelmyto Registry: A Multicenter, Prospective and Retrospective Registry to Evaluate Real World Experience and Outcomes of Patients With Upper Tract Urothelial Cancer (UTUC) Treated With Jelmyto
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 450
- 试验地点
- 44
- 主要终点
- Rate of No Evidence of Disease (NED) at first evaluation post-treatment (investigator assessment)
研究概览
简要总结
The purpose of this registry is to evaluate real world experience and outcomes of patients with Upper Tract Urothelial Cancer (UTUC) treated with Jelmyto in the United States.
详细描述
Patients may be enrolled prospectively, at the time of receiving Jelmyto, or after receiving Jelmyto for retrospective data capture and prospective follow up. Patients will be followed until 3 years after the first dose of Jelmyto or death.
Data will be captured to address specific clinical questions and data gaps related to real world use of Jelmyto.
Example clinical questions:
- How is Jelmyto used in the real world setting?
- What adverse events (AEs) and at what rates and time points are they observed in the real world setting?
- What is the disease volume before and after resection/ablation prior to treating with Jelmyto?
- Did the use of Jelmyto impact clinical decision making and management?
- What is the complete response (CR) rate, duration of response, and rate of progression, including subgroups of interest?
- What are the rates of, time to, and pathology at radical nephroureterectomy (RNU) by response to treatment and number of Jelmyto doses received?
- What are outcomes for non-responders or partial responders? What are the rates of surgical and therapeutic treatment options received following response assessment, including additional Jelmyto?
- What was the outcome of patients with solitary kidney and/or chronic kidney disease (CKD)? Did Jelmyto prevent dialysis by avoiding nephrectomy in solitary kidney or in patients with baseline CKD?
- What is the rate and timing of bladder cancer occurrence and/or recurrences?
研究设计
- 研究类型
- 观察性
- 观察模型
- 队列研究
- 时间视角
- 其他
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
- Adults >18 years old and capable of giving informed consent.
- Diagnosis of UTUC.
- Receipt of at least 1 dose of JELMYTO after FDA approval (15 Apr 2020).
排除标准
- Incapable of giving informed consent (e.g., incarcerated individuals, individuals with dementia).
- Receipt of 1 or more doses of JELMYTO (also referred to as UGN-101 or Mitogel in clinical development) before FDA approval (on or before 15 Apr 2020).
- Pregnancy or lactation.
- Unable to comply with protocol requirements (for prospective data capture).
- Any medical or mental condition(s) that makes participation in the Registry inadvisable in the opinion of the Investigator (for prospective data capture).
研究组 & 干预措施
Jelmyto
Patients with UTUC treated with Jelmyto
干预措施: Jelmyto (mitomycin) for pyelocalyceal solution (Drug)
结局指标
主要结局
Rate of No Evidence of Disease (NED) at first evaluation post-treatment (investigator assessment)
时间窗: 3 months
To evaluate the tumor ablative effect of JELMYTO in the Registry population
Rate of CR or no evidence of disease (NED) at first evaluation post-treatment
时间窗: 3 months
次要结局
- Durability of response at 12, 24, and 36 months in patients who achieve NED after primary treatment with JELMYTO.(3 years)
- Recurrence free survival after adjuvant treatment with JEMLYTO(3 years)
- Time to recurrence(3 years)
- Time to progression(3 years)
- Incidence of JELMYTO-related AEs(3 years)
- Rate of progression(3 years)
- Rates and clinical significance of AEs(3 years)
- Duration of response(3 years)
研究者
研究点 (44)
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标识符
- NCT 编号
- NCT05874921
- 其他研究编号
- UT004
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (明年)
- 研究完成日期
- (4年后)
- 最近核实
- (29天前)
- 最近更新
- (昨天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 是否有结果
- 否
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