The Role and Mechanism of MMR/MSI Phenotypes in Evaluating Vaccine Benefit in Glioblastoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Radiomics
研究概览
简要总结
Glioblastoma (GBM) is the most malignant primary intracranial tumor with a median survival of about 18 months, and new therapies are urgently needed. Tumor vaccines has been shown to improve survival of GBM, but not all patients can benefit from vaccine treatment and biomarkers are urgently needed. Deletion of mismatch repair (MMR) protein and microsatellite instability (MSI) state are important features in the biological evolution of GBM, and may be used as markers for tumor vaccine. Therefore, this project will collect samples from GBM patients before and after vaccine treatment respectively, and evaluate the role of MMR/MSI gene phenotype in predicting vaccine efficacy and the potential molecular mechanism. Moreover, MMR/MSI phenotypes will be assessed by deep-learning and radiomics using images to establish noninvasive markers for vaccine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled
- •They were 18-80 years old, male and female;
- •The pathological results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);
- •Tissue (6 mm * 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
- •Sign informed consent.
排除标准
- •Patients who meet any of the following criteria will not be included in this study:
- •Participants in other clinical trials;
- •Pregnant women.
结局指标
主要结局
Radiomics
时间窗: 36 months
The features from images will be extracted using algorithm of Deep-learning or Radiomics
Transcriptomics
时间窗: 36 months
The issues collected will be used for transcriptome sequencing to measure gene expression level.
Immunomics
时间窗: 36 months
The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes
Genomics
时间窗: 36 months
The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.
IHC analysis
时间窗: 36 months
Different expression level of proteins (CD3,CD8,B7-H4, MMR proteins) in Gliomas with different grades and molecular subgroups (300 cases) will be measured using immunohistochemical.
Proteomics
时间窗: 36 months
The issues collected will be used for TCR/BCR sequencing to measure gene expression level in protein
次要结局
未报告次要终点