NCT05025969已完成不适用
Evaluation of the Incidence of NTRK Gene Fusion in Adult Brain Tumours
GCS Ramsay Santé pour l'Enseignement et la Recherche1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2022年10月31日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- NTRK Fusion
研究概览
简要总结
This is a retrospective, mono centric, exploratory study to assess the incidence of a genomic alteration: NTRK gene fusion, in adult gliomas and brain metastases.
详细描述
Retrospective mono centric study of medical data (clinical, histological, molecular and imaging) from medical records and analysis of available excisional tissue samples.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Adult male or female subject;
- •Glioma or brain metastasis operated on in our institution, histologically confirmed (WHO classification 2016);
- •Subject with a frozen tumour sample < 5 years old;
- •Subject for whom all clinico-radiological data are available;
- •Subject affiliated to a health insurance scheme;
- •Subject who has been informed of the research and who has not indicated his opposition to the use of his medical data and who has signed a consent for the use of his tumour sample.
排除标准
- •Patient under legal protection, guardianship or deprived of liberty by judicial or administrative decision
- •Biological samples not available and/or in insufficient quantity for analysis
结局指标
主要结局
NTRK Fusion
时间窗: through study completion, an average of 12 months
Incidence of NTRK gene fusion identified by RNAseq in glioma and brain metastasis tumour samples.
次要结局
- Progression-free survival in patients with NTRK gene fusion(Month 12)
- Overall survival in patients with NTRK gene fusion.(through study completion, an average of 12 months)
- Specific radiological criterion (perfusion)(through study completion, an average of 12 months)
- NTRK Fusion identification in brain metastasis and primary tumor(through study completion, an average of 12 months)
- Specific radiological criterion (T1)(through study completion, an average of 12 months)
- Specific radiological criterion (T2)(through study completion, an average of 12 months)
- Specific radiological criterion (FLAIR)(through study completion, an average of 12 months)
- Incidence of other genomic alterations(through study completion, an average of 12 months)
研究者
研究点 (1)
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