Developing a Comprehensive Biomarker Panel for Monitoring Progression and Early Detection in ALS Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: peripheral venous blood collection, collection of medical data related to patient care.
- Who it may be relevant to
- Registry conditions: ALS (Amyotrophic Lateral Sclerosis). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other peripheral venous blood collection
collection of an additional 24 mL of blood following a routine blood draw - Other collection of medical data related to patient care
collection of medical data from patient care during the 12-month follow-up period, drawn from electronic medical records, including laboratory test results, clinical examination findings, and paraclinical test results
Primary outcome measures
- Development of a biomarker panel for diagnosis, prognosis, and patient stratification in ALS [Time frame: From baseline to 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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).
- Individuals participating in another research study with an ongoing exclusion period (Article L1121-12).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Montpellier University Hospital — Montpellier
Spain · 1 center
- Hospital Universitari Vall D'Hebron — Barcelona
Identifiers
NCT: NCT07737977 · RECHMPL25_0323