Clinical trial NCT05928416: ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
Official title: ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Amyotrophic Lateral Sclerosis, Sporadic
Amyotrophic Lateral Sclerosis
Keywords: ALS
RNA
Saliva sample
Lead sponsor: ZIWIG
Sponsor class: INDUSTRY
Collaborators: name: Monitoring Force Group
First posted: 2023-07-03
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be made up with amyotrophic lateral sclerosis (ALS) patients defined or probable according to El Escorial criteria ("ALS patients" group) and patients with no medical history or neurological symptoms (Control Group).

The control group will be made up of people accompanying the patients (with or without ALS).

The ALS patients in the study already benefit from routine medical care in ALS expert centers in France. .

The patients concerned by the study are managed without modification of the care pathway, no modification of the therapeutic indications, no modification of the diagnostic examinations or follow-up necessary according to the context, which are carried out according to the recommendations of the HAS.

Brief 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.


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).

Primary outcomes:
measure: Area under the curve (AUC) of the Receiver Operating Curve (ROC)
timeFrame: Through the end of study inclusions, an average of 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU Strasbourg
state: Alsace
city: Saint-Herblain
country: France
facility: CHU Nantes
state: Loire-Atlantique
city: Saint-Étienne
country: France
facility: C.H.U. de Saint-Étienne
state: Loire
city: Bron
country: France
facility: Hospices Civils de Lyon
state: Rhône
city: Angers
country: France
facility: CHU Angers
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Brest
country: France
facility: Hôpital Cavale Blanche
city: Caen
country: France
facility: CHU Caen
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
city: Lille
country: France
facility: CHRU Lille
city: Limoges
country: France
facility: CHU Dupuytren
city: Marseille
country: France
facility: Hôpital de La Timone
city: Montpellier
country: France
facility: CHU Montpellier
city: Nice
country: France
facility: CHU Nice
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
city: Rennes
country: France
facility: CHU Rennes
city: Saint-Pierre
country: France
facility: CHU de la Réunion
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU Bretonneau
Study officials:
References: