Tumor-Derived Extracellular Vesicles for Noninvasive Molecular Classification of Kidney Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Mayo Clinic
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors
研究概览
简要总结
This is a correlative (lab-based) study aiming to identify protein markers in urine extracellular vesicles (EVs) that can be used to develop non-invasive molecular tests for patients with renal cell carcinoma (RCC). Aim 1 will use urine collected previously in biorepository. Aim 2 will prospectively collect blood specimens pre and post nephrectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Urine sample in existing biorepository
- •High-risk renal cell carcinoma (RCC) per American Urological Association (AUA) guidelines
- •Scheduled to undergo nephrectomy
排除标准
- •Does not meet inclusion criteria
结局指标
主要结局
Differentiate tumor-derived extracellular vesicle (tdEV) surface proteins expressed in benign vs malignant renal tumors
时间窗: Baseline
Differential protein expression analysis will be performed on stored urine samples from a biorepository to identify tdEV proteins in each renal cell carcinoma (RCC) subtype (clear-cell, papillary, and chromophobe) versus benign.
Prediction of metastasis after surgery
时间窗: Perioperative (pre- and post-nephrectomy),
Blood samples will be collected pre-and post-nephrectomy to asses for tdEV levels which will be correlated with clinicopathological features to test whether tdEV levels can be used to better predict likelihood of metastasis in patients undergoing curative-intent radical nephrectomy.
次要结局
未报告次要终点