Real World Evidence of PD-L1, TMB Prevalence and Efficacy of 1st Line Chemotherapy in These High or Low Population for Stage IV Urothelial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Prevalence of PD-L1 in stage IV UC patients in real world setting.
研究概览
简要总结
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected to assay PD-L1 expression and next generation sequencer (NGS) assay for tumor mutation burden (TMB).
详细描述
This study is a multi-center, non-interventional study. Patients' background, treatment pattern, treatment outcome, efficacy will be collected from medical records in Stage IV urotherial (UC) patients. Archived patient's formalin-fixed paraffin-embedded (FFPE) primary tumor samples will be collected from each site and conduct programmed cell death 1 ligand 1 (PD-L1) assay and next generation sequencer (NGS) assay for tumor mutation burden (TMB). Based on these data, prevalence of PD-L1, TMB and overall survival (OS), progression free survival (PFS) from start of 1st line treatment in stage IV will be assessed.
In this study, 150 patients will be enrolled from approximately 30 sites in Japan. The patients should have received at least 1 cycle of chemotherapy and never receive immune oncology drug as 1st line treatment in stage IV. The patients will be enrolled continuously from the 1st patient who is enrolled in this study until target number of patients in each site.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 20, Japanese men and women.
- •Patients who have started at least 1 cycle of chemotherapy.
- •Patients who provided informed consent by appropriate methods. In dead case, optout will be applicable.
- •Patients who are diagnosed as stage IV (T4b, any N or any T, N2-3 or M1) UC between January 1st in 2017 and December 31st in
- •Patients who have FFPE primary tumor sample collected after January 1st in
- •The sample should be collected before any therapies including 1st line treatment in stage IV and therapies in stage III and other stages. It is possible to send sliced undyed section of primary tumor including 1 HE-stained section of same sample in case that patients cannot send FFPE primary tumor block.
排除标准
- •Patients who are prior exposure to immune-mediated therapy as 1st line treatment in stage IV.
结局指标
主要结局
Prevalence of PD-L1 in stage IV UC patients in real world setting.
时间窗: Baseline
Summarize number and calculate ratio of PD-L1 high or low/negative patients, respectively.
次要结局
- PFS from start of 1st line treatment in stage IV(18 months)
- Prevalence of TMB in stage IV UC patients in real world setting.(Baseline)
- OS from start of 1st line treatment in stage IV(2 years)