NCT05928416Active, not recruiting
ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
Source: ClinicalTrials.gov · Last updated 27 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 653 (actual)
- First submitted
- 23 Jun 2023
- Start date
- Jul 2023
- Primary completion date
- Nov 2025
- Lead sponsor
- ZIWIG
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT05928416
What you commit to
- Study type: Observational
- Participants enrolled: 653
- From Jul 2023 to the primary completion date, Nov 2025
- 19 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Recent (\<1 month) or ongoing bacterial or viral infection,
- For control group: medical history of neurological disease (excluding migraine).
Other
- 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;
Who the study is looking for
- 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,
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Angers Coordinator of this site? Confirm its status | Angers | France | Unknown status |
| CHU Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Hôpital Cavale Blanche Coordinator of this site? Confirm its status | Brest | France | Unknown status |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Unknown status |
| CHU Caen Coordinator of this site? Confirm its status | Caen | France | Unknown status |
| CHU Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont-Ferrand | France | Unknown status |
| CHRU Lille Coordinator of this site? Confirm its status | Lille | France | Unknown status |
| Chu Dupuytren Coordinator of this site? Confirm its status | Limoges | France | Unknown status |
| Hopital de la Timone Coordinator of this site? Confirm its status | Marseille | France | Unknown status |
| CHU Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Unknown status |
| CHU Nice Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Hôpital de la Pitié-Salpêtrière Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU Rennes Coordinator of this site? Confirm its status | Rennes | France | Unknown status |
| C.H.U. de Saint-Étienne Coordinator of this site? Confirm its status | Saint-Étienne-de-Montluc | France | Unknown status |
| CHU Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Unknown status |
| CHU de la Réunion Coordinator of this site? Confirm its status | Saint-Pierre | France | Unknown status |
| CHU Strasbourg Coordinator of this site? Confirm its status | Strasbourg | France | Unknown status |
| CHU Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Unknown status |
| CHU Bretonneau Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.