Linking the Gut Microbiota to the Prognosis of Glioblastoma Multiforme
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 主要终点
- Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform
研究概览
简要总结
Glioma is the most common primary cancer of the central nervous system, and around 50% of patients present with the most aggressive form of the disease, glioblastoma. Conventional therapies, including surgery, radiotherapy, and pharmacotherapy (typically chemotherapy with temozolomide), have not resulted in major improvements in the survival outcomes with only a median survival of around 15 months.The main reason may be related to the highly immunosuppressive tumor microenvironment. In recent years, the microbiome has emerged as a key regulator of not only systemic immune regulation but brain circuitry, neuro-physiology and microglia development. We hypothesized that there is a link between the gut microbiota and the GBM development and evolution through the immune regulation cells (microglia and tumor related macrophagocyte) in the blood circulation to impact the prognosis( PFS and MST) of GBM patients.
详细描述
We divide the paticipants into three groups. (total number = 200 subjects)
- Radio/Chemotherapy group - 80 subjects
- Radio/ without chemotherapy group - 70 subjects
- Healthy volunteer group - 50 subjects
After the collection of stools before operation and 3 months after the operaton, we will analyze the composition and distribution of gut microbiota, and compare the results of three experiment groups.Then we will followe up the patients and analyze the correlation between gut microbiota and prognosis of GBM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- •The participants diagnosed with glioblastoma multiforme by immunohistochemistry and molecular (IDH1, 1p19q, TERT) diagnosis of WHO 2016 classification of Gliomas.
- •The healthy volunteers.
排除标准
- •No cancer or IBD (inflammatory bowel disease);
- •No history of abdominal surgery;
- •No medication related to gastrointestinal motility within 3 months;
- •No oral antibiotic treatments previous 1 month before neurosurgery operation.
结局指标
主要结局
Pre-operative gut microbiota in molecular subtype glioblastoma mutiforme multiform
时间窗: 12 months
To analysis the distribution and components of gut microbiota before operation
The perturbation of gut microbiota by temozolomide chemotherapy
时间窗: 15 months
To investigate the change of components of gut microbiota induced by chemotherapy
Link the gut microbiota and prognosis of GBM
时间窗: 20 months
To explore the correlation between the gut micriobiota and the prognosis (PFS and MST) by bioinformatic big data process.
次要结局
未报告次要终点