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

NCT05928416 · tracked via the Priya Life Science France tracker

Sponsor

ZIWIG

Phase

Observational

Started

2023-07-11

Last updated

2026-03-27

Condition(s) studied

Amyotrophic Lateral Sclerosis, SporadicAmyotrophic Lateral Sclerosis

Investigational drug(s) / intervention(s)

Saliva sampleSaliva sample

Saliva sample: During the inclusion visit : * a neurological examination is taken * a saliva sample is taken

Saliva sample: During the inclusion visit : * a saliva sample is taken

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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).

Primary outcome measure(s)

Area under the curve (AUC) of the Receiver Operating Curve (ROC) — Through the end of study inclusions, an average of 2 years
Identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in the saliva.

Trial sites (19)

Facility	City	Region
CHU Strasbourg	Strasbourg	Alsace
CHU Nantes	Saint-Herblain	Loire-Atlantique
C.H.U. de Saint-Étienne	Saint-Étienne-de-Montluc	Pays de la Loire Region
Hospices Civils de Lyon	Bron	Rhône
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
CHU Dupuytren	Limoges	France
Hôpital de La Timone	Marseille	France
CHU Montpellier	Montpellier	France
CHU Nice	Nice	France
Hôpital de la Pitié-Salpêtrière	Paris	France
CHU Rennes	Rennes	France
CHU de la Réunion	Saint-Pierre	France
CHU Toulouse	Toulouse	France
CHU Bretonneau	Tours	France

More ZIWIG trials in France

Evaluation of Salivary RNAs in the Presence of an Adnexal Mass of Ovarian Origin Active, not recruiting

Evaluation of Salivary RNA in Subjects Scheduled for Surgery for a Gynecologic Pathology Recruiting

Impact of Ziwig Endotest® on the Management of Patients With Clinical Symptoms of Endometriosis Inconsistent With Their Imaging Work-up Active, not recruiting

Impact of Endotest on Patients' Quality of Life: a Cohort Study Recruiting

Other trials for the same condition

Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments Recruiting

Staging System in Amyotrophic Lateral Sclerosis Active, not recruiting

Alleviating Persistent Dyspnea in Amyotrophic Lateral Sclerosis Patients Treated With Non-Invasive Ventilation Through Immersive Virtual Reality Recruiting

Dazucorilant in Patients With Amyotrophic Lateral Sclerosis Active, not recruiting

Development and Test of a Headset for BCI Until Obtaining an Efficient and Comfortable System That Can be Used in Daily Practice by ALS People Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05928416 on ClinicalTrials.gov ↗ ← All trials in France