NCT02305056终止1 期
Study of Tumor Metabolism by Isotopic Tagging in Patients With High-grade Glioma (CARBONOMIC)
University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mass spectrometry measurement of C13 labelled proteins
研究概览
简要总结
The purpose of the study is to follow tumoral proteins metabolism by in vivo no radioactive isotopic tagging (carbon 13 and nitrogen 15).
详细描述
The project aims to study protein turnover in glioblastoma using mass spectrometry after 13C-valine incorporation. This will allow to identify proteins in circulation secreted by tumor which could be diagnostic and pronostic biomarkers in patients With High-grade Glioma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •more or equal than 18 years old
- •patient affiliated to social security or similarly regime
- •informed consent form signed
- •High-grade Glioma tumor suspicion
- •Resective surgery indication
- •Hematological assessment :
- •neutrophils > 1500/mm3
- •Platelet > 150 000
- •blood Creatinin normal
- •alkaline Phosphatases and transaminases no more than two times normal
- •Bilirubin < 1.5 times normal
排除标准
- •Pregnant women and lactating mothers
- •Ward of court or under guardianship
- •Adult unable to express their consent
- •Person deprived of freedom by judicial or administrative decision
- •Person hospitalized without their consent
- •Person under legal protection
- •Precedent complete macroscopic tumor resective surgery
- •No valid inclusion criteria
- •Intratumoral hemorrhage MRI detected
- •Treatment anticoagulant or antisludge treatments
- •Active Infections and non controled or medical affection or psychiatric intercurrent non treated
- •Evolutive cerebral oedema without corticoid response
- •Non controled Epilepsy without antiepileptics response
- •Karnofsky score < 40%
- •Weight > 100 kg
- •No possibility of resective surgery
研究组 & 干预措施
C13 N15 Valine
Experimental
Intervention C13 N15 Valine
干预措施: C13 N15 Valine (Drug)
结局指标
主要结局
Mass spectrometry measurement of C13 labelled proteins
时间窗: during 30 hours
次要结局
未报告次要终点
研究者
研究点 (1)
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