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Clinical Trials in France / NCT07479017
Starting soon Observational

Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study

NCT07479017 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Tours
Phase
Observational
Started
2026-04
Last updated
2026-03-18

Condition(s) studied

ALS (Amyotrophic Lateral Sclerosis)

Study summary

The search for diagnostic biomarkers that can be used routinely is a major challenge to manage Amyotrophic lateral sclerosis (ALS) in order to characterize the pathophysiology and accelerate the management of the disease. Some non-specific biomarkers have been proposed (Neurofilaments, TDP-43) but their diagnostic value remains controversial. This study aims to identify ALS-specific platelet biomarkers using targeted and untargeted multi-omic approaches, in order to enable differential diagnosis between ALS and other motor neuron diseases.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: Patients with ALS: * Men or women aged 18 to 75 * ALS diagnosed according to the El Escorial criteria * ALS diagnosis less than 3 months ago * Onset of symptoms defined as the time when muscle weakness was first observed by the patient less than 2 years ago Controls with another motor neuron disease: * Men or women aged 18 to 75 * Diagnosis of motor neuron disease \< 3 months Exclusion Criteria: * Genetic variants associated with ALS * Pregnant or breastfeeding women * Treatment with oral or injectable anticoagulants, antiplatelet agents (EXCEPT aspirin at the maximum authorized dosage of 160 mg per day) * Uncontrolled diabetes * Persons deprived of their liberty by judicial or administrative decision * Persons subject to legal protection measures: guardianship or curatorship * Opposition to data processing

Primary outcome measure(s)

  • Diagnostic potential of platelet biomarkers — Enrollment (< 3 months post-diagnosis)
    Platelet biomarkers will be sought using targeted (TDP-43) and non-targeted multiomics screening approaches (transcriptomic, proteomic, metabo-lipidomic). The identified biomarkers will be integrated into multivariate models to evaluate their diagnostic potential in distinguishing ALS from other motor neuron diseases (sensibility, specificity, positive or negative predictive value).

Trial sites (3)

FacilityCityRegionStatus
University hospital, Limoges Limoges France
University hospital, Lyon Lyon France
university hospital, Tours Tours France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07479017 on ClinicalTrials.gov ↗ ← All trials in France