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

March 23, 2026 updated by: ZIWIG

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

653

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France, 49933
        • CHU Angers
      • Bordeaux, France, 33000
        • CHU Bordeaux
      • Brest, France, 29609
        • Hôpital Cavale Blanche
      • Caen, France, 14000
        • CHU Caen
      • Clermont-Ferrand, France, 63003
        • CHU Clermont-Ferrand
      • Lille, France, 59037
        • CHRU Lille
      • Limoges, France, 97042
        • CHU Dupuytren
      • Marseille, France, 13005
        • Hopital de La Timone
      • Montpellier, France, 34295
        • Chu Montpellier
      • Nice, France, 06100
        • CHU Nice
      • Paris, France, 75013
        • Hôpital de la Pitié-Salpêtrière
      • Rennes, France, 35000
        • Chu Rennes
      • Saint-Pierre, France, 97448
        • CHU de la réunion
      • Toulouse, France, 31059
        • CHU Toulouse
      • Tours, France, 37044
        • CHU Bretonneau
    • Alsace
      • Strasbourg, Alsace, France, 67098
        • CHU Strasbourg
    • Loire-Atlantique
      • Saint-Herblain, Loire-Atlantique, France, 44162
        • CHU Nantes
    • Pays de la Loire Region
      • Saint-Étienne-de-Montluc, Pays de la Loire Region, France, 42055
        • C.H.U. de Saint-Étienne
    • Rhône
      • Bron, Rhône, France, 69677
        • Hospices Civils de Lyon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

The study population will be made up with amyotrophic lateral sclerosis (ALS) patients defined or probable according to El Escorial criteria ("ALS patients" group) and patients with no medical history or neurological symptoms (Control Group).

The control group will be made up of people accompanying the patients (with or without ALS).

The ALS patients in the study already benefit from routine medical care in ALS expert centers in France. .

The patients concerned by the study are managed without modification of the care pathway, no modification of the therapeutic indications, no modification of the diagnostic examinations or follow-up necessary according to the context, which are carried out according to the recommendations of the HAS.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SLA group
300 patients
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
Control group
300 patients
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through the end of study inclusions, an average of 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ZIWIG

Collaborators

Monitoring Force Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2023

Primary Completion (Actual)

November 18, 2025

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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