NCT02854449Unknown不适用
Biomarkers of Tumor Response in Hypofractionated Radiotherapy
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Percentage of immune cells
研究概览
简要总结
This study will follow-up different immune cell populations in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of Local Hypofractionated Radiotherapy and a rationale for adjuvant immunotherapy.
详细描述
- Patient information and collection of a signed informed consent form
- Clinical data collection
- Blood samples of 5 mL:
- after registration, prior to the first fraction of radiotherapy
- during radiotherapy sessions
- one month, 3 months after the last radiotherapy session
- Storage of the blood samples at ambient temperature
- Transportation of the samples to the Institute of Biology of Lille (IBL) - CNRS UMR8161 for analysis
- Destruction of the samples at the end of the analysis
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
- 否
入选标准
- •Patient requiring a hypofractionated irradiation;
- •pathologically confirmed Unspecified Adult Solid Tumor
- •Age ≥ 18 years old
- •Signed written informed consent.
排除标准
- •Patient treated by chemotherapy, targeted or immunotherapy within 21 days before the first sampling,
- •Pregnant or breastfeeding woman,
- •Patient under guardianship or tutorship.
结局指标
主要结局
Percentage of immune cells
时间窗: prior to the first fraction of radiotherapy;14(±2) days from the begining of RT; the day (±2) of the last radiotherapy sessions ;one month, 3 months after the last radiotherapy session
The primary endpoint is the change of the percentage of immune cells before, during and after radiotherapy
次要结局
- Local control(3 months)
- Acute and Late toxicities(3 months)
研究者
Celia
Doctor
Peking University First Hospital
研究点 (1)
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