Evaluation of Urinary Exosomes Presence From Clear Cell Renal Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique
研究概览
简要总结
Clear cell renal cell carcinoma is diagnosed by imaging, sometimes associated with biopsy. This diagnosis is expensive, invasive and sometimes late. The development of a simple biological test for diagnosis is essential. Exosomes are 30 to 150 nm membrane vesicles secreted into the extracellular space by various living cells. These exosomes can be isolated from biological fluids, including urine. The recent study of urinary exosomes is a promising topic for analyzing tumor markers in urine. The investigator's goal is to develop a reliable technique for detecting tumor exosomes in urine in patients with clear cell renal cell carcinoma. The analysis of urinary exosomes could provide a new liquid biopsy tool for the early diagnosis of clear cell renal cell carcinoma.
详细描述
The primary objective is to detect urinary exosomes, by electron microscopy technique, from clear cell renal cell carcinoma due to exosome markers (CD9) and clear cell kidney cancer (CA9).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- 否
入选标准
- •All patients with renal mass requiring surgery (partial or total nephrectomy)
- •Social security affiliation
- •Signed informed consent
- •Unscheduled nephrectomy
- •Social security affiliation
- •Signed informed consent
排除标准
- •Insufficient volume of urine sample (< 100 ml)
- •Patients with a urinary catheter
- •Patients under court-ordered guardianship or curators
研究组 & 干预措施
Renal mass patients
Patients with renal mass requiring surgery (partial or total nephrectomy) will be included.
They will have an urinary sample.
干预措施: Urinary sample (Biological)
Control patients
Control patients (without renal mass) will be included. They will have an urinary sample.
干预措施: Urinary sample (Biological)
结局指标
主要结局
Number of patients (with clear cell kidney cancer) with CD9+ and CA9+ exosomes by electron microscopy technique
时间窗: At inclusion
Measured by analysis in electron microscopy technique of urinary sample.
次要结局
- Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer(At inclusion)
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer(At inclusion)
- Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for control patients(At inclusion)
- Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients(At inclusion)
- Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients(At inclusion)
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for control patients(Years: 2)
- Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer(At inclusion)
- Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer(At inclusion)
- Percentage of CD9+/VGEFR2+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer(At inclusion)
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for patients with clear cell kidney cancer(At inclusion)
- Percentage of CD9+ /CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer(At inclusion)
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by electron microscopy technique (%) for control patients(At inclusion)
- Percentage of CD9+ /CA9+ exosomes by electron microscopy technique (%) for patients with clear cell kidney cancer(At inclusion)
- Percentage of CD9+ /CA9+ exosomes by flow cytometry (%) for control patients(At inclusion)
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by flow cytometry (%) for control patients(At inclusion)
- Percentage of CD9+/CD63+/CD81+/CA9+ exosomes by Reverse Transcription quantitative Polymerase Chain Reaction (RT-qPCR) (%) for patients with clear cell kidney cancer(Years: 2)
- Percentage of CD9+/VGEFR2+ exosomes by electron microscopy technique (%) for control patients(At inclusion)
- Percentage of CD9+/VGEFR2+ exosomes by flow cytometry (%) for control patients(At inclusion)