Feasibility of ORGAnoids in Routine Clinical Practice for Molecular Analysis of the GLIOvascular Niche in Patients With Primary Brain Tumors.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Ex-vivo organoid culture feasability
研究概览
简要总结
The main goal of ORGA-GLIO trial is to establish the feasibility in routine clinical practice of ex-vivo organoid cultures composed of tumor cells within their microenvironment (glioblastoma organoid - GBO) and intra- and peri-tumoral blood vessels (blood vessel organoid - BVO), derived from perioperative samples obtained during complete or partial surgical resection in patients with newly diagnosed glioblastoma.
详细描述
The ORGA-GLIO study will be conducted in two stages:
First stage: Establishment of the clinical-biological collection and addressing the primary objective.
Step 1: Generation of tumor organoids (Glioblastoma Organoids - GBO), vascular organoids (Blood Vessel Organoids - BVO), and cell lines.
Step 2: Phenotypic and molecular analyses of tumor and vascular organoids up to 7 days.
Second stage: Utilization of the biological collection of organoids and blood samples.
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
- •Patient, male or female, adult (age ≥ 18 years),
- •Suspected of having a high-grade glioma based on preoperative multimodal MRI,
- •With an indication for tumor resection surgery,
- •And in a clinical condition suitable to undergo adjuvant treatment consisting of radiotherapy (normo- or hypo-fractionated) combined with temozolomide, with or without low-frequency electric fields (Tumor-Treating Fields®).
排除标准
- •Current tumor pathology or history of tumor pathology in remission for less than 2 years
- •Pregnant or breastfeeding women,
- •Patients unable to understand the study for any reason or unable to comply with trial requirements (language barriers, psychological or geographical issues, etc.).
研究组 & 干预措施
Ex-vivo Organoid culture
ex-vivo organoid culture after tumor resection
干预措施: Ex-vivo organoid culture (Other)
结局指标
主要结局
Ex-vivo organoid culture feasability
时间窗: 7 days
Proportion (in number of patients) of phenotypically and molecularly exploitable tumor and vascular organoid models (GBO+BVO) seven days after diagnostic neurosurgical removal (complete or partial excision) in patients with glioblastoma
次要结局
未报告次要终点