NCT05772741招募中不适用
Grafts of Patient-derived Glioblastoma Stem Cells Onto Autologous Brain Organoids. A Precision Medicine Model for Testing Drugs Against Tumor Invasion
Fondazione Policlinico Universitario Agostino Gemelli IRCCS2 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2018年12月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Invasion
研究概览
简要总结
In patients operated for glioblastoma, glioma stem-like cell lines will be obtained from tumor tissue, and IPSCs from skin fibroblasts or PBMCs. Brain organoids will be generated from IPSCs and co-cultured with IPSCs to study brain invasion and ciliogenesis. 3D genome architecture of glioma stem-like cells will be investigated. Gene modulation and pharmacologic strategies to inhibit invasion and restore ciliogenesis will be explored.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •o be enrolled in the study patients must:
- •Have a radiological diagnosis of supratentorial glioblastoma, or
- •Have a radiological diagnosis of first recurrence of a primary supratentorial glioblastoma (for which a formal histopathologic diagnosis of glioblastoma had made at first surgery), according with RANO criteria (Wen, 2010);
- •Be a candidate to neurosurgery for glioblastoma;
- •Be of an age of 18 years or above;
- •Provide written informed consent for participation to the study.
- •Exclusion criteria
- •To be enrolled in the study patients must not:
- •Have not enough pathological material removed at surgery available both for mandatory routine histopathological diagnosis and for the present study, as judged by the Principal Investigator;
- •Have not a definitive pathological diagnosis of a primary supratentorial glioblastoma, according with 2016 WHO classification.
排除标准
- 未提供
结局指标
主要结局
Invasion
时间窗: through study completion, an average of 4 years
Distance travelled by glioma stem cells into brain organoids
Gene assessment
时间窗: through study completion, an average of 4 years
Identification of genes responsible of GSC invasion, among those reportedly involved in self-renewal and ciliogenesis
次要结局
未报告次要终点
研究者
研究点 (2)
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