Amyotrophic Lateral Sclerosis, Amyotrophic Lateral Sclerosis, Sporadic
Conditions
Keywords
ALS, RNA, Saliva sample
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.
Interventions
DIAGNOSTIC_TESTSaliva sample
During the inclusion visit : * a neurological examination is taken * a saliva sample is taken
Sponsors
ZIWIG
Monitoring Force Group
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the curve (AUC) of the Receiver Operating Curve (ROC) | Through the end of study inclusions, an average of 2 years | Identify a diagnostic signature for Amyotrophic Lateral Sclerosis by analyzing of coding and non-coding RNA contained in the saliva. |
Countries
France
Outcome results
None listed