Early Biomarkers of Tumor Response in High Dose Hypofractionated Radiotherapy Word Package 3 : Immune Response
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Analyse of immunological parameters, decription of secreted markers and nanovesicles production
研究概览
简要总结
This study will follow-up immune cell populations, secreted factors and released nanovesicles in the blood before, during and after high dose radiation therapy which should give new information of the efficacy of the hypofractionated high dose radiation therapy 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 35 mL:
- after registration, prior to the first fraction of radiotherapy
- within 15 minutes after the administration of the 1st, the 2nd and the 3rd radiotherapy sessions
- one week, 3 months, 6 months, 9 months and 12 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
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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 (≥ 3 fractions, dose ≥ 9 Gy per fraction) either for :
- •hepatocellular carcinoma or hepatic lesion of metastatic Colorectal Cancer,
- •metastasis from melanoma or renal cancer,
- •Age ≥ 18 years old,
- •Registered with a social security system,
- •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.
研究组 & 干预措施
Blood samples collection
Nine blood samples will be collected in each patient before, during and after radiotherapy treatment.
Interventions :
- Blood samples collection before radiotherapy (T0)
- Blood samples collection during radiotherapy (T1-T3)
- Blood samples collection after radiotherapy (T4-T8)
干预措施: Blood samples collection before radiotherapy (Procedure)
Blood samples collection
Nine blood samples will be collected in each patient before, during and after radiotherapy treatment.
Interventions :
- Blood samples collection before radiotherapy (T0)
- Blood samples collection during radiotherapy (T1-T3)
- Blood samples collection after radiotherapy (T4-T8)
干预措施: Blood samples collection during radiotherapy (Procedure)
Blood samples collection
Nine blood samples will be collected in each patient before, during and after radiotherapy treatment.
Interventions :
- Blood samples collection before radiotherapy (T0)
- Blood samples collection during radiotherapy (T1-T3)
- Blood samples collection after radiotherapy (T4-T8)
干预措施: Blood samples collection after radiotherapy (Procedure)
Blood samples collection
Nine blood samples will be collected in each patient before, during and after radiotherapy treatment.
Interventions :
- Blood samples collection before radiotherapy (T0)
- Blood samples collection during radiotherapy (T1-T3)
- Blood samples collection after radiotherapy (T4-T8)
干预措施: Radiotherapy (Radiation)
结局指标
主要结局
Analyse of immunological parameters, decription of secreted markers and nanovesicles production
时间窗: from baseline to 1 year follow up
Description and evolution of cell fraction, quantification of immune cells, verification of the presence and evolution of activation markers and quantification of secreted exosomes ; before, during and after radiotherapy
次要结局
- Progression-free rate(from baseline to 1 year follow up)
- Number of Participants with Adverse Events related to radiotherapy(from baseline to 1 year follow up)
- Cell viability, determined by number of live/dead cells present(from baseline to 1 year follow up)