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

Amyotrophic Lateral Sclerosis Clinical Trial

— RNALS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928416
• Other study ID #: 2023-01
• Status: Recruiting
• Start date: July 11, 2023
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: ZIWIG
• Contact: Philippe Codron, Dr
• Phone: +33 2 41 35 79 33
• Email: Philippe.codron[@]chu-angers.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Amyotrophic Lateral Sclerosis, Sporadic
• Motor Neuron Disease
• Sclerosis

Intervention

Diagnostic Test:
• Saliva sample
During the inclusion visit : a neurological examination is taken a saliva sample is taken
• Saliva sample
During the inclusion visit : a saliva sample is taken

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
ZIWIG	Monitoring Force Group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve (AUC) of the Receiver Operating Curve (ROC)	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