Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHU Angers
Coordinator of this site? Confirm its status
AngersFranceUnknown status
CHU Bordeaux
Coordinator of this site? Confirm its status
BordeauxFranceUnknown status
Hôpital Cavale Blanche
Coordinator of this site? Confirm its status
BrestFranceUnknown status
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
BronFranceUnknown status
CHU Caen
Coordinator of this site? Confirm its status
CaenFranceUnknown status
CHU Clermont-Ferrand
Coordinator of this site? Confirm its status
Clermont-FerrandFranceUnknown status
CHRU Lille
Coordinator of this site? Confirm its status
LilleFranceUnknown status
Chu Dupuytren
Coordinator of this site? Confirm its status
LimogesFranceUnknown status
Hopital de la Timone
Coordinator of this site? Confirm its status
MarseilleFranceUnknown status
CHU Montpellier
Coordinator of this site? Confirm its status
MontpellierFranceUnknown status
CHU Nice
Coordinator of this site? Confirm its status
NiceFranceUnknown status
Hôpital de la Pitié-Salpêtrière
Coordinator of this site? Confirm its status
ParisFranceUnknown status
CHU Rennes
Coordinator of this site? Confirm its status
RennesFranceUnknown status
C.H.U. de Saint-Étienne
Coordinator of this site? Confirm its status
Saint-Étienne-de-MontlucFranceUnknown status
CHU Nantes
Coordinator of this site? Confirm its status
Saint-HerblainFranceUnknown status
CHU de la Réunion
Coordinator of this site? Confirm its status
Saint-PierreFranceUnknown status
CHU Strasbourg
Coordinator of this site? Confirm its status
StrasbourgFranceUnknown status
CHU Toulouse
Coordinator of this site? Confirm its status
ToulouseFranceUnknown status
CHU Bretonneau
Coordinator of this site? Confirm its status
ToursFranceUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.