Evaluation of Metabolomic Analysis in Early Diagnosis of ALS

NCT ID: NCT01962311

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2018-02-28

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.

Conditions

ALS

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

All patients

lumbar puncture

Group Type: EXPERIMENTAL

lumbar puncture

Intervention Type: PROCEDURE

lumbar puncture at enrollment in study

Interventions

lumbar puncture

lumbar puncture at enrollment in study

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Tours

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christian ANDRES, MD-PHD

Role: STUDY_DIRECTOR

University Hospital TOURS and INSERM U930

Locations

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

Angers, , France

Service de Neurologie et Pathologie du Mouvement Clinique de Neurologie, Pôle des Neurosciences et de l'Appareil Locomoteur INSERM U 837

Lille, , 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, CHU La Milétrie, POITIERS, Faculté de Médecine

Poitiers, , France

University Hospital

Strasbourg, , France

CHRU -TOURS-Service de Neurologie

Tours, , France

Countries

France

Other Identifiers

2012-A00145-38

Identifier Type: OTHER

Identifier Source: secondary_id

PHRN11-CA-METABALS

Identifier Type: -

Identifier Source: org_study_id