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

Ziwig

Status

Enrolling

Conditions

Amyotrophic Lateral Sclerosis

Amyotrophic Lateral Sclerosis, Sporadic

Treatments

Diagnostic Test: Saliva sample

Study type

Observational

Funder types

Industry

Identifiers

NCT05928416

2023-01

Details and patient eligibility

About

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.

Enrollment

600 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Patient over 18 years of age,
Patient from one of the 2 study populations:
- Diagnosis of definite or probable ALS according to El Escorial criteria ("patients ALS" group) ;
- Control group
Patient able to carry out a mouth rinse,
Patient affiliated to the healthcare system,
Patient has dated and signed the consent form,

Exclusion criteria

Recent (<1 month) or ongoing bacterial or viral infection,
Known active oral or digestive mycosis,
Evolving, symptomatic or obvious oral pathology,
Known pregnancy,
Patient participating in another clinical research study,
Patient deprived of liberty by administrative or judicial decision or under guardianship ;
Subject refusing to take a saliva sample;
For the control group: direct relationship (siblings, descendants, ascendants) with a patient included in the study;
For control group: medical history of neurological disease (excluding migraine).