Defining the Genomic and Histologic Landscape of Primary and Metastatic Tumors With Divergent Kinetics in Patients With Renal Cell Carcinoma (RCC) and Urothelial Carcinoma (UC) Treated With Immune Checkpoint Blockade (ICB)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Histopathological characterization of samples from ICB treated patients
研究概览
简要总结
This is a comparative study using resected/ biopsied tumors samples collected from renal cell carcinoma and urothelial carcinoma patients who underwent surgical removal of lesions, followed by immune checkpoint blockade (ICB) treatment targting programmed cell death 1 (PD1) but developed new lesions later were also removed and stored in the biosample repository (BSR). The histology and genomic analysis of the pre-treatment and metastatic samples from the same patient would be used to find out the changes that may have lead to metastasis. Also, metastatic samples from ICB naive patients would be collected and compared with those from ICB treated patients to find out if the metastasis in treated patients was due to development of reistance.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients will include retrospectively identified patients with RCC or UC who have received treatment with ICB and achieved clinical benefit but subsequently developed a solitary new/progressive lesion that was removed surgically. Patients with other tumor types who otherwise meet criteria may be included at a later time
- •Additionally, a group of patients with RCC who have undergone a metastasectomy but who did not receive treatment with ICB will be identified. These patients may be approached for study participation to serve as a comparator group
排除标准
- 未提供
研究组 & 干预措施
Patients treated with immune check point blocker
Patients who were treated with immune checkpoint inhibitor targeting PD1 and developed metastatic lesion later
干预措施: Immune checkpoint inhibitor targeting PD1 (Biological)
结局指标
主要结局
Histopathological characterization of samples from ICB treated patients
时间窗: 18 months
To characterize differences in histopathology and patterns of genomic expression between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)
Genomic characterization of samples from ICB treated patients
时间窗: 18 months
To characterize expression of different genes between baseline tumors and metastases exhibiting divergent growth kinetics ("escape" metastases) in patients treated with immune checkpoint blockade (ICB)
次要结局
- Comparison of genomic characteristics of metastatic samples from ICB naive and treated patients(18 months)
- Comparison of Histopathological characteristics of metastatic samples from ICB naive and treated patients(18 months)
- Genomic characterization of samples from patients treated with targeted or observational therapy(18 months)
- Histopathological characterization of samples from patients treated with targeted or observational therapy(18 months)