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| Name | Class |
|---|---|
| Monitoring Force Group | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SLA group | 300 patients |
| |
| Control group | 300 patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saliva sample | Diagnostic Test | During the inclusion visit :
|
|
| 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 |
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Inclusion Criteria:
Patient over 18 years of age,
Patient from one of the 2 study populations:
Patient able to carry out a mouth rinse,
Patient affiliated to the healthcare system,
Patient has dated and signed the consent form,
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Strasbourg | Strasbourg | Alsace | 67098 | France | ||
| CHU Nantes |
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Saliva
| Saliva sample | Diagnostic Test | During the inclusion visit :
|
|
| Saint-Herblain |
| Loire-Atlantique |
| 44162 |
| France |
| C.H.U. de Saint-Étienne | Saint-Étienne-de-Montluc | Pays de la Loire Region | 42055 | France |
| Hospices Civils de Lyon | Bron | Rhône | 69677 | France |
| CHU Angers | Angers | 49933 | France |
| CHU Bordeaux | Bordeaux | 33000 | France |
| Hôpital Cavale Blanche | Brest | 29609 | France |
| CHU Caen | Caen | 14000 | France |
| CHU Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| CHRU Lille | Lille | 59037 | France |
| CHU Dupuytren | Limoges | 97042 | France |
| Hôpital de La Timone | Marseille | 13005 | France |
| CHU Montpellier | Montpellier | 34295 | France |
| CHU Nice | Nice | 06100 | France |
| Hôpital de la Pitié-Salpêtrière | Paris | 75013 | France |
| CHU Rennes | Rennes | 35000 | France |
| CHU de la Réunion | Saint-Pierre | 97448 | France |
| CHU Toulouse | Toulouse | 31059 | France |
| CHU Bretonneau | Tours | 37044 | France |
| ID | Term |
|---|---|
| C531617 | Amyotrophic lateral sclerosis 1 |
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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