Diagnosing ALS using saliva samples and RNA analysis

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

This study is trying to see if analyzing saliva samples can help doctors diagnose ALS more easily by comparing results from ALS patients and healthy individuals.

Quick facts

• Study type: Observational
• Enrollment: 600 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ziwig (Industry-sponsored)
• Locations: 19 sites (Strasbourg, Alsace and 18 other locations)
• Trial ID: NCT05928416 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify a diagnostic signature for Amyotrophic Lateral Sclerosis (ALS) by analyzing coding and non-coding RNA in saliva samples. It involves two groups: patients diagnosed with definite or probable ALS and a control group consisting of caregivers and individuals without neurological history. The study is conducted in ALS reference centers in France, ensuring that participants continue their routine medical care without any modifications. The analysis focuses on the potential of saliva as a non-invasive diagnostic tool for ALS.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with a diagnosis of definite or probable ALS or those in the control group without neurological history.

Not a fit: Patients with recent infections, known oral pathologies, or those with a direct relationship to ALS patients in the study may not benefit.

Why it matters

Potential benefit: If successful, this study could lead to a more accessible and non-invasive method for diagnosing ALS.

How similar studies have performed: While the approach of using saliva for ALS diagnosis is innovative, similar studies have shown promise in other conditions, indicating potential for success.

Eligibility criteria

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).

Where this trial is running

Strasbourg, Alsace and 18 other locations

• CHU Strasbourg — Strasbourg, Alsace, France (Not_yet_recruiting)
• CHU Nantes — Saint-Herblain, Loire-Atlantique, France (Recruiting)
• C.H.U. de Saint-Étienne — Saint-Étienne, Loire, France (Not_yet_recruiting)
• Hospices Civils de Lyon — Bron, Rhône, France (Recruiting)
• CHU Angers — Angers, France (Recruiting)
• CHU Bordeaux — Bordeaux, France (Not_yet_recruiting)
• Hôpital Cavale Blanche — Brest, France (Recruiting)
• CHU Caen — Caen, France (Recruiting)
• CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
• CHRU Lille — Lille, France (Recruiting)
• CHU Dupuytren — Limoges, France (Not_yet_recruiting)
• Hôpital de La Timone — Marseille, France (Recruiting)
• CHU Montpellier — Montpellier, France (Recruiting)
• CHU Nice — Nice, France (Recruiting)
• Hôpital de la Pitié-Salpêtrière — Paris, France (Recruiting)
• CHU Rennes — Rennes, France (Recruiting)
• CHU de la Réunion — Saint-Pierre, France (Recruiting)
• CHU Toulouse — Toulouse, France (Recruiting)
• CHU Bretonneau — Tours, France (Recruiting)

Study contacts

• Study coordinator: Philippe Codron, Dr

Conditions Amyotrophic Lateral Sclerosis, Sporadic; Amyotrophic Lateral Sclerosis; ALS; RNA; Saliva sample