Characterization of Platelet Molecular Profiles in ALS for the Identification of Specific Diagnostic Biomarkers - A Pilot Study

NCT07479017 | Not Yet Recruiting

• 1 other identifier: DR250240 - SLA-PlaQ
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

ALS (Amyotrophic Lateral Sclerosis)

Keywords

diagnostic biomarkers; platelet molecular profiles

Outcome Measures

Primary Outcomes (1)

• 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).

  Enrollment (< 3 months post-diagnosis)

Secondary Outcomes (4)

• Diagnostic performances of platelet biomarkers compared to plasma neurofilaments

  Enrollment (<3 months post-diagnosis)

• Relationships between platelet biomarkers, neurofilaments and clinical characteristics

  Enrollment (<3 months post-diagnosis)

• Discriminatory capacity of platelet molecular signatures

  Enrollment (<3 months post-diagnosis)

• Prognostic value of platelets biomarkers at diagnosis on ALS functional rating scale (ALSFRS-R) score progression after one year

  Functional evolution between enrolment (<3months post-diagnosis) and 12 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ALS or another MND followed in 3 ALS centers

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (3)

University hospital, Limoges

Limoges, 87000, France

Location

University hospital, Lyon

Lyon, 69000, France

Location

university hospital, Tours

Tours, 37044, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

2 tubes of 7 ml of blood upon inclusion

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Hélène BLASCO, Pr

CONTACT

234378911; helene.blasco@univ-tours.fr

Noémie EYRAUD

CONTACT

247478060; n.eyraud@chu-tours.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2026
• First Posted: March 18, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

FR (3)