Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

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.

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Key information

Conditions

ALS Disease Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Patients treated with RILUZOLE
Enrollment in an other study

Treatment and study plan

Lumbar Puncture

Procedure

lumbar puncture at enrollment in study

Primary outcomes

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: METABALS

Important dates

Study start: 2013
Primary completion: 2017
Study completion: 2018
First posted: Oct 14, 2013
Registry last updated: Jul 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed