RNALS: ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| SLA group 300 patients |
Diagnostic Test: Saliva sample
During the inclusion visit :
a saliva sample is taken
|
| Control group 300 patients |
Diagnostic Test: Saliva sample
During the inclusion visit :
a neurological examination is taken
a saliva sample is taken
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
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,
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Patient has dated and signed the consent form,
Exclusion Criteria:
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Recent (<1 month) or ongoing bacterial or viral infection,
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Known active oral or digestive mycosis,
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Evolving, symptomatic or obvious oral pathology,
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Known pregnancy,
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Patient participating in another clinical research study,
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Patient deprived of liberty by administrative or judicial decision or under guardianship ;
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Subject refusing to take a saliva sample;
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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).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Angers | Angers | France | 49933 | |
| 2 | CHU Bordeaux | Bordeaux | France | 33000 | |
| 3 | Hôpital Cavale Blanche | Brest | France | 29609 | |
| 4 | CHU Caen | Caen | France | 14000 | |
| 5 | CHU Clermont-Ferrand | Clermont-Ferrand | France | 63003 | |
| 6 | CHRU Lille | Lille | France | 59037 | |
| 7 | CHU Dupuytren | Limoges | France | 97042 | |
| 8 | Hôpital de La Timone | Marseille | France | 13005 | |
| 9 | CHU Montpellier | Montpellier | France | 34295 | |
| 10 | CHU Nice | Nice | France | 06100 | |
| 11 | Hôpital de la Pitié-Salpêtrière | Paris | France | 75013 | |
| 12 | CHU Rennes | Rennes | France | 35000 | |
| 13 | CHU de la Réunion | Saint-Pierre | France | 97448 | |
| 14 | CHU Toulouse | Toulouse | France | 31059 | |
| 15 | CHU Bretonneau | Tours | France | 37044 |
Sponsors and Collaborators
- ZIWIG
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2023-01