ClinicalTrials.gg
Not yet recruitingNCT07737977UNZUELUZON ALSUpdated Jul 30, 2026

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

An observational study in ALS (Amyotrophic Lateral Sclerosis), sponsored by University Hospital, Montpellier. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • ALS (Amyotrophic Lateral Sclerosis)

Keywords

  • ALS
  • Biomarkers
  • Amyotrophic Lateral Sclerosis
  • Diagnosis
  • Prognosis
  • Disease Progression
  • Patient Stratification
  • Blood Biomarkers
  • Motor Neuron Disease
  • Neurodegeneration
03

In context

Amyotrophic Lateral Sclerosis

978 studies on the registry are indexed under Amyotrophic Lateral Sclerosis; 277 are open to participants now.

This study's planned enrollment of 200 is above the median of 108 across 265 observational studies indexed under Amyotrophic Lateral Sclerosis.

Browse Amyotrophic Lateral Sclerosis studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,261 studies on the registry; 224 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants with amyotrophic lateral sclerosis (ALS) meeting the El Escorial diagnostic criteria. Both sporadic and familial ALS cases, including spinal-onset and bulbar-onset phenotypes, are eligible for participation. Participants will be recruited at Montpellier University Hospital, a specialized ALS center, and will provide blood samples and clinical data for biomarker analyses.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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).
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • patients with ALS

    ALS patients under follow-up

    Other: peripheral venous blood collection · Other: collection of medical data related to patient care

Interventions

  • Otherperipheral venous blood collection

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

  • Othercollection 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

06

What researchers measure

Primary outcomes

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

    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).

    Time frame: From baseline to 12 months

07

Study locations

2 sites
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07737977
Responsible party
Sponsor
First posted
Jul 30, 2026
Start date
Aug 2026 (estimated)
Primary completion
Feb 2029 (estimated)
Completion
Aug 2029 (estimated)
Last update
Jul 30, 2026

Study contacts

Florence ESSELIN, MD
Contact
motoneuronerech@chu-montpellier.fr
04 67 33 09 56 ext. +33
Florence ESSELIN, MD
principal investigator · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion