Interest of Measuring P2X4 Receptors on Blood Monocytes as a Diagnostic Marker in Amyotrophic Lateral Sclerosis: P2X4 as a Diagnostic Biomarker for ALS
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: P2X4 receptors in blood samples.
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis &Amp; Other Neuromuscular Disorders. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Amyotrophic lateral sclerosis (ALS) is the most common form of motor neuron disease and is characterized by the degeneration of motor neurons leading to progressive paralysis and death within 3 to 5 years after diagnosis. To date, no key mechanism had been identified. Our associated laboratory has identified the P2X4 purinergic pathway that appears to be involved in the pathogenesis of ALS. Our goal is to verify these results at the human level in order to have a proof of concept of P2X4's role as a biomarker of the disease.
Interventions
- Diagnostic test P2X4 receptors in blood samples
This is an interventional study designed to assay P2X4 receptors in blood samples from ALS patients and healthy volunteers by comparing the mean levels of P2X4 expression.
Primary outcome measures
- Expression of P2X4 receptor [Time frame: 6 months after Day 0]
Secondary outcome measures (5)
- Diagnostic performance [Time frame: 6 months after Day 0]
- Prognostic performances [Time frame: 6 months after Day 0]
- P2X4 receptor levels evolution [Time frame: 6 months after Day 0]
- Levels of P2X4 receptors between patients with familial or sporadic ALS. [Time frame: 6 months after Day 0]
- P2X4 receptor levels of patients with a SOD1 mutation treated with anti-SOD1antisense [Time frame: 6 months after Day 0]
Eligibility criteria
Inclusion criteria
- For ALS group: Person presenting a probable or confirmed diagnosis of ALS according to the criteria of EI Escorial.
- Adult.
- Person affiliated or beneficiary of a social security scheme.
- Free, informed and written consent signed by the participant or by a third person (in case of physical incapacity of the participant), after information on the study.
Exclusion criteria
- People undergoing immunosuppressive or corticosteroid treatments.
- Participation in a research protocol with an experimental treatment.
- People placed under guardianship, curatorship or legal protection.
- For healthy volunteer, people directly related to the patient (siblings, descendants and ancestry).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Hôpital Pellegrin — Bordeaux
Identifiers
NCT: NCT07091799 · CHUBX 2024/82