NCT05928416

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 653 (actual)
• Sponsor: ZIWIG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Amyotrophic Lateral Sclerosis, Sporadic
• Amyotrophic Lateral Sclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Saliva sample	During the inclusion visit : * a neurological examination is taken * a saliva sample is taken
DIAGNOSTIC_TEST	Saliva sample	During the inclusion visit : * a saliva sample is taken

Timeline

• Start date: 2023-07-11
• Primary completion: 2025-11-18
• Completion: 2026-05-01
• First posted: 2023-07-03
• Last updated: 2026-03-27

Locations

19 sites across 1 country: France