- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02670226
Muscular Biomarkers in Amyotrophic Lateral Sclerosis (METABOMU)
Metabolomics and Transcriptomics Approaches to Identify Muscular Biomarkers in Amyotrophic Lateral Sclerosis
Study Overview
Detailed Description
Amyotrophic Lateral Sclerosis (ALS), the most common MND, is a fatal adult-onset neuromuscular disease. Due to clinical heterogeneity and absence of biological tools to diagnose ALS, the delay between the first symptoms and diagnosis averages 9-13 months. A group of pathophysiological processes, including oxidative stress and glutamate-mediated excitotoxicity contribute to cell death, but the triggering factor, the timing and the interaction of different cellular events await elucidation [2]. Unknown pathogenesis for most patients means few available treatments. The search for biomarkers that can aid diagnosis, characterize phenotype, define pathophysiology, identify endpoints in trials and measure disease progression is of utmost importance for the field. Some studies have advocated that muscle per se may be impaired by pathogenesis of the diseases. Muscle has been poorly studied and its central role in energetic metabolism suggests that this tissue, quite easily available, should be more analyzed to find biomarkers and to compare muscular metabolism with those of brain and overall body. Specific aims of our subjects are:
Specific aims are focused on:
- the acquisition of metabolites profiles of the muscle, blood and satellite cells using an analytical platform enable a deep exploration. For that, the use of three analytical modalities (NMR, mass spectrometry coupled to GC or UPLC) ensures the best coverage of the metabolite population with a high range of concentration variability and molecular diversity.
- the building of metabolites profiles models that discriminate pathological and control situations.
- the identification of metabolites implicated in the discriminant model.
- the generation of metabolism pathways hypothesis related to the discriminant model.
- the acquisition of transcriptomics data to confirm and add complementary results to metabolomics data
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tours, France, 37044
- Service de chirurgie orthopédique et traumatologique, CHRU de TOURS
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Tours, France, 37044
- Service de Neurologie, CHRU de TOURS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Case group selection criteria:
Inclusion Criteria:
- Age ≥ 18 years and ≥ 75 years
- ALS according to the El Escorial criteria
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Exclusion Criteria:
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Contraindication to local anesthesia
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Treatment against cramps or twitching may affect muscle metabolism
Control group selection criteria:
Inclusion Criteria:
- Age ≥ 18 years and ≥ 75 years
- No neuronal disease
- Patients affiliated to social security scheme
- Informed consent signed by the patient
Exclusion Criteria:
- Pregnant or breastfeeding women
- Contraindication to biopsy
- Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
- Unbalanced Diabetes
- Systemic corticosteroid treatment
- Treatment against cramps or twitching may affect muscle metabolism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: Case group
The intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis
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Blood samples, muscle biopsy
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Other: Control group
The intervention, specific to the study, is to take samples at baseline on patients without neurological disease
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Blood samples, muscle biopsy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Metabolic signature of muscle
Time Frame: At baseline
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Metabolomics profile using NMR and LC-HRMS
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At baseline
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Metabolic signature of blood
Time Frame: At baseline
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Metabolomics profile using NMR and LC-HRMS
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At baseline
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Metabolic signature of satellites cells
Time Frame: At baseline
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Metabolomics profile using NMR and LC-HRMS
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At baseline
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Expression levels of targeted genes using transcriptomics
Time Frame: At baseline
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Choice of genes based on results obtained by metabolomics approaches
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At baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hélène BLASCO, MD, helene.blasco@univ-tours.fr
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHAO15-HB-METABOMU
- 2015-A01629-40 (Other Identifier: IdRCB)
- 151550B-31 (Other Identifier: ASNM)
- 2016-R3 (Other Identifier: CPP)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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