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Clinical Trials/NCT01962311
NCT01962311
Completed
Not Applicable

Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

University Hospital, Tours6 sites in 1 country82 target enrollmentFebruary 2013
ConditionsALS

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ALS
Sponsor
University Hospital, Tours
Enrollment
82
Locations
6
Primary Endpoint
Diagnostic markers studied are metabolites of cerebrospinal fluid, blood and urine measured by three complementary analytical methods
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
February 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Patients treated with RILUZOLE
  • Enrollment in an other study

Outcomes

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

Study Sites (6)

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