NCT02670226

Brief Summary

The first objective is to find some biomarkers, or a profile of biomarkers of ALS to help to diagnosis. The second objective is to better understand the pathogenesis of this disease by the exploration of muscle, blood and satellite cells metabolomes and transcriptomes.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 1, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

March 29, 2016

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2019

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

3.5 years

First QC Date

January 14, 2016

Last Update Submit

December 15, 2025

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral SclerosisMuscle metabolismMetabolomicsTranscriptomics

Outcome Measures

Primary Outcomes (3)

  • Metabolic signature of muscle

    Metabolomics profile using NMR and LC-HRMS

    At baseline

  • Metabolic signature of blood

    Metabolomics profile using NMR and LC-HRMS

    At baseline

  • Metabolic signature of satellites cells

    Metabolomics profile using NMR and LC-HRMS

    At baseline

Secondary Outcomes (1)

  • Expression levels of targeted genes using transcriptomics

    At baseline

Study Arms (2)

Case group

OTHER

The intervention, specific to the study, is to take samples at baseline on patients with Amyotrophic Lateral Sclerosis

Other: Samples

Control group

OTHER

The intervention, specific to the study, is to take samples at baseline on patients without neurological disease

Other: Samples

Interventions

SamplesOTHER

Blood samples, muscle biopsy

Case groupControl group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • Age ≥ 18 years and ≥ 75 years
  • No neuronal disease
  • Patients affiliated to social security scheme
  • Informed consent signed by the patient
  • Pregnant or breastfeeding women
  • Contraindication to biopsy
  • Treatment with oral or injectable anticoagulants, antiplatelet (except aspirin)
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Service de chirurgie orthopédique et traumatologique, CHRU de TOURS

Tours, 37044, France

Location

Service de Neurologie, CHRU de TOURS

Tours, 37044, France

Location

Related Publications (1)

  • Lanznaster D, Bruno C, Bourgeais J, Emond P, Zemmoura I, Lefevre A, Reynier P, Eymieux S, Blanchard E, Vourc'h P, Andres CR, Bakkouche SE, Herault O, Favard L, Corcia P, Blasco H. Metabolic Profile and Pathological Alterations in the Muscle of Patients with Early-Stage Amyotrophic Lateral Sclerosis. Biomedicines. 2022 Jun 2;10(6):1307. doi: 10.3390/biomedicines10061307.

    PMID: 35740329RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Sampling Studies

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Study CharacteristicsEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Hélène BLASCO, MD

    helene.blasco@univ-tours.fr

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2016

First Posted

February 1, 2016

Study Start

March 29, 2016

Primary Completion

October 15, 2019

Study Completion

December 9, 2019

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)