In Situ Immune Parameters and Their Prognostic Role on the Survival of Patients With Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 5
- 主要终点
- overall survival
研究概览
简要总结
Glioblastoma (GBM) is the most frequent brain tumor. Currently survival is poor and few treatments are available. Recent data show that there is no immune privilege of the central nervous system (CNS) and that GBM are invaded by effector CD8 T cells, letting us hypothesis that GBM growth is dependent of immunosurveillance.
The aim of this study is to better understand the antitumor immune response against GBM to unravel new effectors and immunosuppressive pathways important for the regulation of anticancer immunity and to discover new immune activating strategies with the objectives to isolate subgroups of GBMs that could benefit from an immunotherapy approach. To achieve this goal, GBM tumor samples and a blood sample will be collected during the initial tumor resection.
The sites involved in the recruitment of the patients will be the neurosurgical teams in Brussel, Dijon, Nantes and Padova.
详细描述
Primary objective :
The primary objective is to determine for each of the 3 molecular subtypes of glioblastoma the predictive performance on 1-year overall survival of in situ immune parameters
Secondary objectives :
To identify the best combination of in vivo immune parameters that is predictive of 1-year overall survival To determine the impact of immune parameters on overall survival Create a collection of biological samples
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly diagnosed, brain tumor
- •Gross or near total resection of the contrast-enhancing tumor mass decides by the neurosurgeron.
- •Subjects ≥18 and ≤75 years of age at surgery
- •Patients must be able to understand and sign the informed consent documents indicating that they are aware of the investigational nature of this study.
- •Confirmation of the diagnosis of grade IV GBM by the local pathologist with an independent neuropathologist who will review this diagnosis
- •Primary therapy must consist of surgical resection with the intent for a gross or near total resection of the contrast-enhancing tumor mass, followed by conventional external beam radiation therapy and concurrent temozolomide chemotherapy.
- •Tumor biopsy for biological analysis has to be performed before using ultrasonic surgery
排除标准
- •Patient with other type of primary brain tumor or metastases
- •Patients with only biopsy performed for the diagnosis
- •Subjects under guardianship, curatorship or judicial protection
- •Female subjects who are pregnant or breast-feeding
结局指标
主要结局
overall survival
时间窗: 24 months
Determination for each of the 3 molecular subtypes of glioblastoma the predictive performance on 1-year overall survival of in situ immune parameters
次要结局
未报告次要终点