Immunophenotype Characterization of Circulating and Tumor Infiltrating Immune Cells in Malignant Brain Tumors.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Baseline leucocytes count
研究概览
简要总结
The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome.
Participants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.
详细描述
High-grade gliomas are the most frequent type of primary brain tumor in adults, and among them, glioblastoma multiforme (GBM) is the most malignant with an associated poor prognosis. Although significant advances have been achieved in GBM biology comprehension, patients' life expectancy is still limited to 18 months.
Brain metastases (BM) are the most frequent neoplasm in the CNS; it is estimated that up to 14% of all newly diagnosed cancers will soon or later metastasize into the brain.
A variety of mechanisms to escape a tumor-specific T cell-mediated immune response have been identified in glioma and other cancer entities.
This project is an observational, prospective, monocentric study on patients candidates for neurosurgical procedures for brain malignant tumors with additional collection of biological material. With the present study, we aim to characterize the phenotype of both circulating- and tumor-infiltrating- immune cells at the diagnosis and their changes during disease progression and after treatment in primary and secondary brain tumors.
Samples will be taken at baseline (before surgery) and at time-points: 3, 6, 9, 12 months
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
- 未提供
排除标准
- •Patients who do not meet inclusion criteria.
结局指标
主要结局
Baseline leucocytes count
时间窗: Baseline
Leucocytes count (10\^3/ml), total lymphocytes count (10\^3/ml)
Baseline leucocytes immunophenotype
时间窗: Baseline
Determination of different leucocyte subpopulations (%)
Baseline tumor-infiltrating leucocytes immunophenotype
时间窗: After surgery (tumor sampling)
Infiltrating T-cell subpopulations (%)
Baseline tumor-infiltrating lymphocytes count
时间窗: After surgery (tumor sampling)
Infiltrating lymphocytes count (10\^3/ml)
次要结局
未报告次要终点
研究者
Pietro Mortini, MD, Prof.
Professor
IRCCS San Raffaele