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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

ALS (Amyotrophic Lateral Sclerosis) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Disease Disease Attributes Disease Progression Metabolic Diseases Motor Neuron Disease Nerve Degeneration Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montpellier University Hospital, Montpellier, Occitanie, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

peripheral venous blood collection

Other

collection of an additional 24 mL of blood following a routine blood draw

collection of medical data related to patient care

Other

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 outcomes

Development of a biomarker panel for diagnosis, prognosis, and patient stratification in ALS

Time frame: From baseline to 12 months

A multivariable biomarker panel integrating clinical variables, genetic variants associated with ALS survival, and serum protein and immunological biomarkers will be evaluated. Biomarkers include cytokines, neurofilament light chain (NF-L), GFAP, phosphorylated TDP-43, TDP-43, total Tau, phosphorylated Tau, and UCHL1, together with genotyping of ALS-associated survival variants. The panel will be assessed for its ability to support prognosis and patient stratification in amyotrophic lateral sclerosis (ALS).

Study contacts

Contact information is provided by the study sponsor or research team.

Florence ESSELIN, MD

CONTACT

[email protected]

04 67 33 09 56 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Registry information

Acronym: UNZUELUZON ALS

Important dates

Study start: 2026
Primary completion: 2029
Study completion: 2029
First posted: Jul 30, 2026
Registry last updated: Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Not Yet Recruiting