ALS (Amyotrophic Lateral Sclerosis)UNZUELUZON ALSNCT07737977
Developing a Comprehensive Biomarker Panel for Monitoring Progression and Early Detection in ALS Patients
An observational study of ALS (Amyotrophic Lateral Sclerosis), run by University Hospital, Montpellier at 2 sites in 2 countries.
Trial summary
Amyotrophic lateral sclerosis (ALS) is a progressive neurodegenerative disease for which reliable biomarkers for early diagnosis, prognosis, and patient stratification remain limited. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- What is being tested?
- peripheral venous blood collection and collection of medical data related to patient care
- How many people
- 200 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2026to Aug 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Spain1 site
Hospital Universitari Vall D'Hebron
Barcelona, 08035
Raúl Juntas Morales, MD PhD
About this study
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.
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Being tested
- peripheral venous blood collection, collection of medical data related to patient care
- Keywords
- ALS, Biomarkers, Amyotrophic Lateral Sclerosis, Diagnosis, Prognosis, Disease Progression, Patient Stratification, Blood Biomarkers, Motor Neuron Disease, Neurodegeneration
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Disease, Disease Progression, Motor Neuron Disease, Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral venous blood collectionOther
collection of an additional 24 mL of blood following a routine blood draw
collection of medical data related to patient careOther
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
| Study group | Role | What they receive |
|---|---|---|
| patients with ALS | ALS patients under follow-up Receives: Other: peripheral venous blood collection; Other: collection of medical data related to patient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2026
- Study startAug 2026 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionAug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ALS (Amyotrophic Lateral Sclerosis)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron Research Institute
- Responsible party
- Sponsor
- Investigators
- Florence ESSELIN, MD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07737977
- Sponsor's protocol ID
- RECHMPL25_0323
- Acronym
- UNZUELUZON ALS
- Status last verified
- Jul 2026
- First submitted
- 27 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Comprehensive Biomarker Panel for Monitoring Progression and Early Detection in ALS Patients
- ClinicalTrials.gov ID
- NCT07737977
- Acronym / sponsor ID
- UNZUELUZON ALS / RECHMPL25_0323
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- ALS, Biomarkers, Amyotrophic Lateral Sclerosis, Diagnosis, Prognosis, Disease Progression, Patient Stratification, Blood Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hospital Universitari Vall d'Hebron Research Institute
- Study start
- Aug 2026 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Aug 2029 (estimated)
- First posted
- 30 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with ALS | – | Other: peripheral venous blood collection, Other: collection of medical data related to patient careALS patients under follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral venous blood collectioncollection of an additional 24 mL of blood following a routine blood draw | Other | patients with ALS |
| collection of medical data related to patient carecollection 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 | Other | patients with ALS |
Primary outcome
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florence ESSELIN, MD principal investigator
University Hospital, Montpellier
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ALS (Amyotrophic Lateral Sclerosis), run by University Hospital, Montpellier at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florence ESSELIN, MD (04 67 33 09 56 ext. +33, motoneuronerech@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of a biomarker panel for diagnosis, prognosis, and patient stratification in ALS (time frame: From baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026; AzTrials last refreshed its copy on 26 Oct 2026.