Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

Not Applicable

Completed

• Conditions: ALS
• Interventions: Procedure: lumbar puncture

• Registration Number: NCT01962311
• Lead Sponsor: University Hospital, Tours

Brief Summary

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

A blood test that would allow the diagnosis

1. to reduce the time between the first signs and diagnosis in ALS patients for therapeutic treatment earlier and

2. 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:

1. attempt to improve the predictive power of markers assays by adding new parameters

2. to check whether the assayed molecules in other environments more accessible (blood, urine) would provide equivalent diagnostic power of those assayed in the CSF

3. identify metabolic pathways disrupted early that could be related to the pathogenesis of neurodegeneration.

Study Timeline

• Study First Submitted: 2013-01-15
• Study Start: 2013-02
• Study First Submitted QC: 2013-10-11
• Study First Posted: 2013-10-14
• Primary Completion: 2017-02
• Study Completion: 2018-02
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-16
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

• age 30-80
• Consent signed
• affiliation to a social security organism

Exclusion Criteria

• Patients treated with RILUZOLE
• Enrollment in an other study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All patients	lumbar puncture	lumbar puncture

Primary Outcome Measures

Name	Time	Method
Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods	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

Trial Locations

Locations (6)

University Hospital; 🇫🇷 Strasbourg, France

Pôle Neurosciences et Spécialités ,Service de Neurologie,CHU d'Angers; 🇫🇷 Angers, France

CHRU -TOURS-Service de Neurologie; 🇫🇷 Tours, France

Centre de Recherche de l'Institut du Cerveau et de la moëlle UPMC Paris 6,Département des Maladies du Système Nerveux; 🇫🇷 Paris, France

Service de Neurologie et Pathologie du Mouvement Clinique de Neurologie, Pôle des Neurosciences et de l'Appareil Locomoteur INSERM U 837; 🇫🇷 Lille, France

Service de neurologie, CHU La Milétrie, POITIERS, Faculté de Médecine; 🇫🇷 Poitiers, France