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

N/AActive Not RecruitingNCT05928416

ZIWIG653 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

653

Conditions

Amyotrophic Lateral Sclerosis, Sporadic Amyotrophic Lateral Sclerosis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (19)

CHU Strasbourg

Strasbourg, Alsace, France

CHU Nantes

Saint-Herblain, Loire-Atlantique, France

C.H.U. de Saint-Étienne

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

Hospices Civils de Lyon

Bron, Rhône, France

CHU Angers

Angers, France

CHU Bordeaux

Bordeaux, France

Hôpital Cavale Blanche

Brest, France

CHU Caen

Caen, France

CHU Clermont-Ferrand

Clermont-Ferrand, France

CHRU Lille

Lille, France

...and 9 more locations

Outcomes

Primary Outcomes

Area under the curve (AUC) of the Receiver Operating Curve (ROC)

Identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in the saliva.

Time frame: Through the end of study inclusions, an average of 2 years