Prospective Evaluation of T-cell Immune Status in Patients With Newly Diagnosed High Grade Gliomas
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Changes in T Cell subtypes and cytokines as a function of treatment
研究概览
简要总结
The primary goal of this study is evaluate T cell immune status and immune reconstitution and the association with specific cytokines in patients with newly diagnosed HGGs undergoing the standard RT/TMZ and adjuvant TMZ.
详细描述
Numbers of T-cell subtypes at six time points in patients with newly diagnosed HGGs undergoing standard RT/TMZ and adjuvant TMZ:
- Baseline within 2 weeks before initiation of RT/TMZ
- At the end of RT/TMZ approximately week 6
- Before adjuvant TMZ approximately week 10
- After 2 cycle of TMZ approximately week 18
- After 4 cycle of TMZ approximately week 26
- Three month after last cycle of TMZ
Secondary Endpoints
- Changes in serial T cell subtypes and cytokines levels
- Incidence of lymphopenia related infections
- Changes in T-cell numbers and subtypes with TMZ administration
- Overall survival
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Patients must be at least 18 years of age.
- •Patients must have histologically confirmed new diagnosed high grade glioma by pathology (WHO grade III and IV).
- •Patients proposed post-operative treatment plan must include standard radiation and temozolomide.
- •Patients must have a Karnofsky performance status ≥ 60% (i.e. the patient must be able to care for himself/herself with occasional help from others).
- •Patients must be able to provide written informed consent.
- •Steroid use is allowed.
排除标准
- •Patients with HIV are excluded.
研究组 & 干预措施
Standard Care Pts Eval of T-Cell Immune Status
Pts undergoing standard radiation/TMZ and adjuvant TMZ will have blood collections at 6 different time points throughtout their treatment to evaluate T Cell changes
干预措施: Blood collections (Procedure)
结局指标
主要结局
Changes in T Cell subtypes and cytokines as a function of treatment
时间窗: 6 time points in pts undergoing standard RT/TMZ and adjuvant TMZ
baseline approx 6wks approx 10wks aprox 18wks approx 26wks 3 months after last cycle of TMZ
次要结局
未报告次要终点