Evaluation of Metabolomic Analysis in Early Diagnosis of ALS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 12
- 主要终点
- Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods
研究概览
简要总结
This project is expected to answer the question of interest assays of metabolites in the CSF as a tool for early diagnosis and should show whether it is possible or not to use such markers in the blood or urine. These studies should also help shed light on the pathophysiological original early clinical disease. While ALS appears to be more a clinical syndrome that pathophysiological entity unique metabolic abnormalities identified could help identify mechanisms disrupted in which therapeutic interventions will be possible.
详细描述
A blood test that would allow the diagnosis
- to reduce the time between the first signs and diagnosis in ALS patients for therapeutic treatment earlier and
- to exclude rapidly non ALS in their avoiding unnecessary investigations and anxiety of being infected with a terrible prognosis disease. It is currently accepted that neurodegenerative diseases such as ALS begin before the first clinical signs and the patient could benefit from a more efficient care if it was early.
Conduct a prospective study with 400 patients.
The secondary objectives are:
- attempt to improve the predictive power of markers assays by adding new parameters
- to check whether the assayed molecules in other environments more accessible (blood, urine) would provide equivalent diagnostic power of those assayed in the CSF
- identify metabolic pathways disrupted early that could be related to the pathogenesis of neurodegeneration.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 30-80
- •Consent signed
- •affiliation to a social security organism
排除标准
- •Patients treated with RILUZOLE
- •Enrollment in an other study
研究组 & 干预措施
All patients
lumbar puncture
干预措施: lumbar puncture (Procedure)
结局指标
主要结局
Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods
时间窗: 2 years
diagnostic criteria Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods: GC / MS, LC / MSMS and proton NMR spectroscopy. These metabolites, the number of one hundred, can be grouped into four main groups: molecules of metabolism of carbohydrates, lipids, proteins, steroids
次要结局
未报告次要终点