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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Amyotrophic Lateral Sclerosis, Sporadic Amyotrophic Lateral Sclerosis Amyotrophic lateral sclerosis 1 Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Strasbourg, Strasbourg, Alsace, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Saliva sample

Diagnostic Test

During the inclusion visit :

a neurological examination is taken
a saliva sample is taken

Primary outcomes

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

Time frame: 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.

Sponsors and collaborators

Lead sponsor

ZIWIG

Industry

Collaborators

Monitoring Force Group

Registry information

Acronym: RNALS

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2026
First posted: Jul 3, 2023
Registry last updated: Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed