Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

Conditions
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ALS

Intervention / Treatment
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* Procedure: lumbar puncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 30-80 Consent signed affiliation to a social security organism Exclusion Criteria: Patients treated with RILUZOLE Enrollment in an other study

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br>lumbar puncture | Procedure: lumbar puncture<br>* lumbar puncture at enrollment in study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods | 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 | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALS, Spinal Cerebrospinal Fluid, Urine, SERUM, Diagnosis