Informations générales (source: ClinicalTrials.gov)

NCT05928416 En recrutement
ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach (RNALS)
Observational
  • Sclérose latérale amyotrophique
  • Sclérose
  • Maladies du motoneurone
juillet 2023
juillet 2025
29 juin 2024
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.

Etablissements

Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
C.H.U. de Saint-Étienne - 42055 - Saint-Étienne - Loire - France Jean Philippe Camdesanché, Pr Recrutement non commencé Contact (sur clinicalTrials)
CHRU Lille - 59037 - Lille - France Véronique Danel, Dr En recrutement Contact (sur clinicalTrials)
CHU Angers - 49933 - Angers - France Philippe Codron, Dr En recrutement Contact (sur clinicalTrials)
CHU Bordeaux - 33000 - Bordeaux - France Gwendal Le Masson, Pr Recrutement non commencé Contact (sur clinicalTrials)
CHU Bretonneau - 37044 - Tours - France Philippe Corcia, Pr En recrutement Contact (sur clinicalTrials)
CHU Caen - 14000 - Caen - France Mathilde Leffliatre, Dr En recrutement Contact (sur clinicalTrials)
CHU Clermont-Ferrand - 63003 - Clermont-Ferrand - France Nathalie Guy, Dr En recrutement Contact (sur clinicalTrials)
CHU de la Réunion - 97448 - Saint-Pierre - France Ariane Choumert, Dr En recrutement Contact (sur clinicalTrials)
CHU Dupuytren - 97042 - Limoges - France Philippe Couratier, Pr Recrutement non commencé Contact (sur clinicalTrials)
CHU Montpellier - 34295 - Montpellier - France Elisa De La Cruz, Dr En recrutement Contact (sur clinicalTrials)
CHU Nantes - 44162 - Saint-Herblain - Loire-Atlantique - France Claire Boutoleau Bretonière, Dr En recrutement Contact (sur clinicalTrials)
CHU Nice - 06100 - Nice - France Marie-Hélène Soriani, Dr En recrutement Contact (sur clinicalTrials)
CHU Rennes - 35000 - Rennes - France Paul Sauleau, Pr En recrutement Contact (sur clinicalTrials)
CHU Strasbourg - 67098 - Strasbourg - Alsace - France Marie-Céline Fleury, Dr Recrutement non commencé Contact (sur clinicalTrials)
CHU Toulouse - 31059 - Toulouse - France Pascal Cintas, Dr En recrutement Contact (sur clinicalTrials)
Hôpital Cavale Blanche - 29609 - Brest - France Steeve Genestet, Dr En recrutement Contact (sur clinicalTrials)
Hôpital de la Pitié-Salpêtrière - 75013 - Paris - France Gaëlle Bruneteau, Pr En recrutement Contact (sur clinicalTrials)
Hôpital de La Timone - 13005 - Marseille - France Annie Verschueren, Dr En recrutement Contact (sur clinicalTrials)
Hospices Civils de Lyon - 69677 - Bron - Rhône - France Emilien Bernar, Dr En recrutement Contact (sur clinicalTrials)

Critères

Tous
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,



- 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).