ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach

RNALS is a multicentre, transversal, diagnostic and non-interventional study carried out in ALS reference centers; in order to identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in patients saliva. The study population consists of patients with definite or probable amyotrophic lateral sclerosis (ALS) according to the El Escorial criteria ("ALS Subjects" group) and subjects with no neurological history (Control group). The control group will be made up of caregivers of patients with ALS, and caregivers of patients with a pathology other than ALS. The ALS patients concerned by the study already benefit from routine medical care in ALS expert centers in France. The patients concerned by the study will be managed without modification of the care pathway, nor modification of the therapeutic indications, nor modification of the diagnostic or follow-up examinations necessary according to the context, which are carried out according to the recommendations of the HAS, CNGOF.

NCT Number	NCT05928416
Lead Sponsor	ZIWIG Collaborators: Monitoring Force Group
Conditions	Amyotrophic Lateral Sclerosis, Sporadic, Amyotrophic Lateral Sclerosis
Enrollment	653 participants
Start Date	2023-07-11
Primary Completion	2025-11-18 (estimated)
Study Completion	2026-05 (estimated)
Updated on ClinicalTrials.gov	2026-03-27