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

Study Overview
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Brief Summary
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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.

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

Conditions
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Amyotrophic Lateral Sclerosis, Sporadic, Amyotrophic Lateral Sclerosis

Intervention / Treatment
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* Diagnostic Test: Saliva sample
* Diagnostic Test: Saliva sample


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| SLA group<br>300 patients | Diagnostic Test: Saliva sample<br>* During the inclusion visit : a saliva sample is taken<br>|
| Control group<br>300 patients | Diagnostic Test: Saliva sample<br>* During the inclusion visit : a neurological examination is taken a saliva sample is taken<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ALS, RNA, Saliva sample