A Multi-center, Prospective, Observational Study of Analysis of Q Cell Markers in Patients With Newly Diagnosed Primary Glioblastoma (Phase IV)
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- The effect of each single molecular marker of Q cell on overall survival
研究概览
简要总结
The purpose of this study is to determine whether Q cells separated from the glioma sample are determinants in treatment response and prognosis of glioma patients
详细描述
The unique markers of Qcell were screened using the method of genomics and
proteomics, then these markers will be qualitatively and quantitatively evaluated in
glioblastoma patients by comparing their relationship with overrall
survival/progression-free survival and treatment response.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>=18 years old
- •Primary Glioblastoma is newly diagnosed and confirmed histologically
- •Patient is expected to be treated with temozolomide and followed up routinely at the study site.
- •Willing to sign the informed consent
排除标准
- •Currently enrolled in any other clinical study
- •History of any other malignancies
- •Refusal to give consent
- •No available tumor tissue for IDH analysis.
结局指标
主要结局
The effect of each single molecular marker of Q cell on overall survival
时间窗: 3-5 days postoperatively
Participating centres collected data and submitted it by Email to the coordinating centre at the Nanfang Glioma Center. 300 patients with glioblastoma will be prospectively enrolled in this study. The unique markers of Q cell which had been screened using the method of genomics and proteomics will be measured and compared with progression-free and overall survival of patients. Regrettably,the markers of Q cell cannot yet be disclosed because of the confidentiality requirement. Progression-free survival (PFS) will be calculated from the day of first surgery until tumor progression, death, or end of follow-up. Overall survival (OS) will be calculated from the day of first surgery until death or end of follow-up. The effect of each single molecular marker on PFS and OS was investigated using the Cox proportional hazards model.
The effect of each single molecular marker of Q cell on progression-free survival
时间窗: 3-5 days postoperatively
Participating centres collected data and submitted it by Email to the coordinating centre at the Nanfang Glioma Center. 300 patients with glioblastoma will be prospectively enrolled in this study. The unique markers of Q cell which had been screened using the method of genomics and proteomics will be measured and compared with progression-free and overall survival of patients. Regrettably,the markers of Q cell cannot yet be disclosed because of the confidentiality requirement. Progression-free survival (PFS) will be calculated from the day of first surgery until tumor progression, death, or end of follow-up. Overall survival (OS) will be calculated from the day of first surgery until death or end of follow-up. The effect of each single molecular marker on PFS and OS was investigated using the Cox proportional hazards model.
次要结局
- We will correlate molecular markers of Q cell with other genetic alterations(3-5 days postoperatively)