Measuring P2X4 receptors on blood monocytes to help diagnose ALS
Interest of Measuring P2X4 Receptors on Blood Monocytes as a Diagnostic Marker in Amyotrophic Lateral Sclerosis: P2X4 as a Diagnostic Biomarker for ALS
We will test whether measuring P2X4 receptors on blood monocytes can help diagnose ALS in adults with suspected or confirmed disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Bordeaux Academic / other |
| Locations | 1 site (Bordeaux) |
| Trial ID | NCT07091799 on ClinicalTrials.gov |
What this trial studies
Researchers will collect blood samples from adults with probable or confirmed ALS, from people with other neuromuscular disorders, and from healthy volunteers, then measure P2X4 receptor levels on monocytes. The study aims to confirm prior laboratory findings that the P2X4 purinergic pathway is linked to ALS and to provide a proof of concept for a blood-based biomarker. Participants on immunosuppressive or corticosteroid treatments, those in experimental treatment protocols, or individuals under legal protection are excluded. The work is conducted at Hôpital Pellegrin, University Hospital of Bordeaux, using standardized blood sampling and receptor quantification methods.
Who should consider this trial
Good fit: Adults with a probable or confirmed diagnosis of ALS by El Escorial criteria, who can provide informed consent and are not taking immunosuppressive or corticosteroid medications, are the ideal candidates.
Not a fit: People on immunosuppressive or corticosteroid treatments, those unable to give consent, individuals under guardianship, and close relatives of patients (for healthy volunteer arm) are not eligible and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this could lead to a simple blood test that helps clinicians diagnose ALS earlier and more accurately.
How similar studies have performed: This is a novel clinical application: laboratory studies suggest a role for P2X4 in ALS but clinical validation of P2X4 as a diagnostic biomarker is not yet established.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Bordeaux
- Hôpital Pellegrin — Bordeaux, France (Recruiting)
Study contacts
- Study coordinator: Gwendal Le Masson, Pr
- Email: gwendal.le-masson@chu-bordeaux.fr
- Phone: 05 57 82 13 70
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.