Evaluation of Metabolomic Analysis in Early Diagnosis of ALS
METABALS
2 other identifiers
interventional
82
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2013
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2013
CompletedStudy Start
First participant enrolled
February 1, 2013
CompletedFirst Posted
Study publicly available on registry
October 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedJuly 17, 2019
July 1, 2019
4 years
January 15, 2013
July 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
All patients
EXPERIMENTALlumbar puncture
Interventions
Eligibility Criteria
You may qualify if:
- age 30-80
- Consent signed
- affiliation to a social security organism
You may not qualify if:
- Patients treated with RILUZOLE
- Enrollment in an other study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Pôle Neurosciences et Spécialités ,Service de Neurologie,CHU d'Angers
Angers, 49933, France
Service de Neurologie et Pathologie du Mouvement Clinique de Neurologie, Pôle des Neurosciences et de l'Appareil Locomoteur INSERM U 837
Lille, 59037, France
Centre de Recherche de l'Institut du Cerveau et de la moëlle UPMC Paris 6,Département des Maladies du Système Nerveux
Paris, 75013, France
Service de neurologie, CHU La Milétrie, POITIERS, Faculté de Médecine
Poitiers, 86021, France
University Hospital
Strasbourg, 67000, France
CHRU -TOURS-Service de Neurologie
Tours, 37044, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christian ANDRES, MD-PHD
University Hospital TOURS and INSERM U930
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2013
First Posted
October 14, 2013
Study Start
February 1, 2013
Primary Completion
February 1, 2017
Study Completion
February 1, 2018
Last Updated
July 17, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share