Developing a Comprehensive Biomarker Panel for Monitoring Progression and Early Detection in ALS Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Montpellier

About this trial

Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease for which reliable biomarkers for early diagnosis, prognosis, and patient stratification remain limited. Previous genetic, proteomic, imaging, and electrophysiological studies have identified potential biomarkers and phenotype modifiers, improving the understanding of motor neuron degeneration mechanisms. However, these findings have not yet been translated into a clinically useful biomarker algorithm. This observational study aims to develop a biomarker panel to support the diagnosis, prognosis, and stratification of patients with ALS. Clinical and molecular biomarkers previously associated with ALS phenotypes will be analyzed simultaneously and integrated into a multivariable predictive model. Clinical data and biological samples will be collected and analyzed to identify combinations of biomarkers associated with ALS phenotypes.

Eligibility criteria

Qualifiers

Age greater than 18 years.

Male and female patients with ALS diagnosed according to the El Escorial diagnostic criteria.

Sporadic or familial ALS cases.

Spinal-onset or bulbar-onset ALS cases.

Disqualifiers

Refusal to participate.

Individuals deprived of liberty (Article L1121-6), including those subject to judicial or administrative decisions or involuntary hospitalization.

Adults under legal protection (guardianship, curatorship, or judicial protection measures) (Article L1121-8).

Individuals not affiliated with, or not beneficiaries of, a French social security scheme (Article L1121-8-1).

Trial design

Treatments tested in this trial

  • peripheral venous blood collection
  • collection of medical data related to patient care

Treatment groups

200 Participants
are divided into 1 treatment group

Sponsors and collaborators

University Hospital, Montpellier

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Collaborator