ALS (Amyotrophic Lateral Sclerosis)SLA-PlaQNCT07479017
Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study
An observational study of ALS (Amyotrophic Lateral Sclerosis), run by University Hospital, Tours at 3 sites in France.
Trial summary
The search for diagnostic biomarkers that can be used routinely is a major challenge to manage Amyotrophic lateral sclerosis (ALS) in order to characterize the pathophysiology and accelerate the management of the disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ALS (Amyotrophic Lateral Sclerosis)
- How many people
- 60 participants
- Where
- 3 sitesFrance
- Study dates
- Apr 2026to Aug 2027
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ALS or another MND followed in 3 ALS centers
Who may be able to join
- Patients with ALS:
- Men or women aged 18 to 75
- ALS diagnosed according to the El Escorial criteria
- ALS diagnosis less than 3 months ago
- Onset of symptoms defined as the time when muscle weakness was first observed by the patient less than 2 years ago
- Controls with another motor neuron disease:
- Men or women aged 18 to 75
- Diagnosis of motor neuron disease < 3 months
Who cannot join
- Genetic variants associated with ALS
- Pregnant or breastfeeding women
- Treatment with oral or injectable anticoagulants, antiplatelet agents (EXCEPT aspirin at the maximum authorized dosage of 160 mg per day)
- Uncontrolled diabetes
- Persons deprived of their liberty by judicial or administrative decision
- Persons subject to legal protection measures: guardianship or curatorship
- Opposition to data processing
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
University hospital, Limoges
Limoges, 87000
Philippe COURATIER, Pr, 555056559 ext. +33, philippe.couratier@chu-limoges.fr
Philippe COURATIER, Pr
University hospital, Lyon
Lyon, 69000
Emilien BERNARD, Dr, +33472357218 ext. +33, emilien.bernard@chu-lyon.fr
Emilien BERNARD, Dr
university hospital, Tours
Tours, 37044
Philippe CORCIA, Pr, 247473724 ext. +33, philippe.corcia@univ-tours.fr
Philippe CORCIA, Pr
About this study
The search for diagnostic biomarkers that can be used routinely is a major challenge to manage Amyotrophic lateral sclerosis (ALS) in order to characterize the pathophysiology and accelerate the management of the disease. Some non-specific biomarkers have been proposed (Neurofilaments, TDP-43) but their diagnostic value remains controversial. This study aims to identify ALS-specific platelet biomarkers using targeted and untargeted multi-omic approaches, in order to enable differential diagnosis between ALS and other motor neuron diseases.
Read the detailed description
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive loss of motor neurons, leading to increasing muscle paralysis. The pathophysiology of ALS remains poorly understood, and the absence of a diagnostic test makes this disease a real challenge, requiring an average of 12 months before a reliable ALS diagnosis can be established. Yet, this disease progresses rapidly, leading to death on average 36 months after the onset of symptoms. The search for diagnostic biomarkers that can be used routinely is therefore a major challenge in order to characterize the pathophysiology and accelerate the management of the disease. To date, a few avenues have been explored, including the concentration in the blood or cerebrospinal fluid of neurofilaments, a protein that can be used to assess the progression of neuronal loss. This biomarker has shown some potential but is not specific to ALS and its diagnostic value remains controversial. In addition, the TDP-43 protein, involved in RNA metabolism, has been widely described as pathogenic in ALS. Indeed, its aggregation and modification of its localization are thought to be associated with motor neuron degeneration. Several studies have demonstrated the presence of this protein in platelets, suggesting their potential as a source of peripheral biomarkers. This project aims to identify platelet molecular biomarkers in ALS patients within three months of diagnosis, using targeted (TDP-43 and neurofilaments) and non-targeted (metabo-lipidomic, transcriptomic, and proteomic profiles) approaches. This multi-omic approach could reveal a complex, comprehensive, and specific signature of ALS. The results will allow us to evaluate the diagnostic and prognostic performance of platelet biomarkers, either on their own or in combination.
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- diagnostic biomarkers, platelet molecular profiles
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALS patients | Biological: A blood sample will be taken at the time of inclusion by increasing the volume taken for the health routine care. | |
| control patients with another motor neuron disease | Biological: A blood sample will be taken at the time of inclusion by increasing the volume taken for the health routine care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic potential of platelet biomarkers
Platelet biomarkers will be sought using targeted (TDP-43) and non-targeted multiomics screening approaches (transcriptomic, proteomic, metabo-lipidomic). The identified biomarkers will be integrated into multivariate models to evaluate their diagnostic potential in distinguishing ALS from other motor neuron diseases (sensibility, specificity, positive or negative predictive value).
Measured: Enrollment (< 3 months post-diagnosis)
Secondary outcomes (4)
Diagnostic performances of platelet biomarkers compared to plasma neurofilaments
Plasma neurofilament concentration will be measured in each participant's sample. Diagnostic potential of platelet biomarkers will be compared to that of plasma neurofilaments concentration. The platelet biomarkers previously identified and plasma neurofilament concentration will be integrated into multivariate models to evaluate and compare their diagnostic potential in distinguishing ALS from other motor neuron diseases.
Measured: Enrollment (<3 months post-diagnosis)
Relationships between platelet biomarkers, neurofilaments and clinical characteristics
To better understand the pathophysiology of ALS, relationships with clinical characteristics will be investigated: weight, height, medical history, ALSFRS-r, King's and Milano-Torino scales, Forced Vital Capacity, symptom onset, site of onset, age of onset and concomitant treatments.
Measured: Enrollment (<3 months post-diagnosis)
Discriminatory capacity of platelet molecular signatures
The capacity to discriminate distinct clinical endophenotype of ALS patients according to platelet molecular signatures will be evaluated using multivariate models.
Measured: Enrollment (<3 months post-diagnosis)
Prognostic value of platelets biomarkers at diagnosis on ALS functional rating scale (ALSFRS-R) score progression after one year
Capacity of platelet biomarkers measured within 3 months post-diagnosis to predict functional progression of ALS (i.e. the percentage change in ALSFRS-R score between diagnosis and one year later)
Measured: Functional evolution between enrolment (<3months post-diagnosis) and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (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.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07479017
- Sponsor's protocol ID
- DR250240 - SLA-PlaQ
- Acronym
- SLA-PlaQ
- Status last verified
- Mar 2026
- First submitted
- 3 Mar 2026
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study
- ClinicalTrials.gov ID
- NCT07479017
- Acronym / sponsor ID
- SLA-PlaQ / DR250240 - SLA-PlaQ
- Conditions
- ALS (Amyotrophic Lateral Sclerosis)
- Keywords
- diagnostic biomarkers, platelet molecular profiles
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 18 Mar 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.
The search for diagnostic biomarkers that can be used routinely is a major challenge to manage Amyotrophic lateral sclerosis (ALS) in order to characterize the pathophysiology and accelerate the management of the disease. Some non-specific biomarkers have been proposed (Neurofilaments, TDP-43) but their diagnostic value remains controversial. This study aims to identify ALS-specific platelet biomarkers using targeted and untargeted multi-omic approaches, in order to enable differential diagnosis between ALS and other motor neuron diseases.
Detailed description
Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease characterized by progressive loss of motor neurons, leading to increasing muscle paralysis. The pathophysiology of ALS remains poorly understood, and the absence of a diagnostic test makes this disease a real challenge, requiring an average of 12 months before a reliable ALS diagnosis can be established. Yet, this disease progresses rapidly, leading to death on average 36 months after the onset of symptoms. The search for diagnostic biomarkers that can be used routinely is therefore a major challenge in order to characterize the pathophysiology and accelerate the management of the disease. To date, a few avenues have been explored, including the concentration in the blood or cerebrospinal fluid of neurofilaments, a protein that can be used to assess the progression of neuronal loss. This biomarker has shown some potential but is not specific to ALS and its diagnostic value remains controversial. In addition, the TDP-43 protein, involved in RNA metabolism, has been widely described as pathogenic in ALS. Indeed, its aggregation and modification of its localization are thought to be associated with motor neuron degeneration. Several studies have demonstrated the presence of this protein in platelets, suggesting their potential as a source of peripheral biomarkers. This project aims to identify platelet molecular biomarkers in ALS patients within three months of diagnosis, using targeted (TDP-43 and neurofilaments) and non-targeted (metabo-lipidomic, transcriptomic, and proteomic profiles) approaches. This multi-omic approach could reveal a complex, comprehensive, and specific signature of ALS. The results will allow us to evaluate the diagnostic and prognostic performance of platelet biomarkers, either on their own or in combination.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ALS patients | – | –Biological: A blood sample will be taken at the time of inclusion by increasing the volume taken for the health routine care. |
| control patients with another motor neuron disease | – | –Biological: A blood sample will be taken at the time of inclusion by increasing the volume taken for the health routine care. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ALS or another MND followed in 3 ALS centers
Key inclusion criteria (8 listed)
- Men or women aged 18 to 75
- ALS diagnosed according to the El Escorial criteria
- ALS diagnosis less than 3 months ago
- Onset of symptoms defined as the time when muscle weakness was first observed by the patient less than 2 years ago
- Men or women aged 18 to 75
Key exclusion criteria (7 listed)
- Genetic variants associated with ALS
- Pregnant or breastfeeding women
- Treatment with oral or injectable anticoagulants, antiplatelet agents (EXCEPT aspirin at the maximum authorized dosage of 160 mg per day)
- Uncontrolled diabetes
- Persons deprived of their liberty by judicial or administrative decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic potential of platelet biomarkers
Time frame: Enrollment (< 3 months post-diagnosis)
Platelet biomarkers will be sought using targeted (TDP-43) and non-targeted multiomics screening approaches (transcriptomic, proteomic, metabo-lipidomic). The identified biomarkers will be integrated into multivariate models to evaluate their diagnostic potential in distinguishing ALS from other motor neuron diseases (sensibility, specificity, positive or negative predictive value).
4 secondary outcomes
Diagnostic performances of platelet biomarkers compared to plasma neurofilaments
Time frame: Enrollment (<3 months post-diagnosis)
Relationships between platelet biomarkers, neurofilaments and clinical characteristics
Time frame: Enrollment (<3 months post-diagnosis)
Discriminatory capacity of platelet molecular signatures
Time frame: Enrollment (<3 months post-diagnosis)
Prognostic value of platelets biomarkers at diagnosis on ALS functional rating scale (ALSFRS-R) score progression after one year
Time frame: Functional evolution between enrolment (<3months post-diagnosis) and 12 months
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 18 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
3 sites in 1 country: 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, Tours at 3 sites in France.
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 8 inclusion and 7 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 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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 Hélène BLASCO, Pr (234378911 ext. +33, helene.blasco@univ-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic potential of platelet biomarkers (time frame: Enrollment (< 3 months post-diagnosis)). 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 18 Mar 2026.