NCT04883827已完成不适用
Monitoring Disease Burden and Biology Using Tumor Cell Free DNA in Metastatic Kidney Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 3
- 主要终点
- Evaluate tumor cfDNA as a dynamic marker of response to IO therapy
研究概览
简要总结
This study will assess whether DNA released by kidney cancer into the blood stream and urine of patients can be used to monitor tumor burden and tumor response to treatment in patients receiving immunotherapy
详细描述
Primary Objective:
- Evaluate tumor cell free (cf)DNA as a dynamic marker of response to immuno-oncology (IO) therapy
Exploratory Objective:
- Collect data on somatic mutations in cfDNA to gain insight into the biology of IO-responders and -non-responders
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 是
入选标准
- •Renal Cell Carcinoma with clear cell component
- •Receiving IO-containing regimen
- •Measurable disease per RECIST 1.1
排除标准
- •Active cancer (exclusion criteria only for healthy patient cohort)
结局指标
主要结局
Evaluate tumor cfDNA as a dynamic marker of response to IO therapy
时间窗: Up to about 2 years
Measure of changes in the amount of tumor DNA correlated with result of routine tumor imaging studies
次要结局
未报告次要终点
研究者
Scott Haake, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center
研究点 (3)
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