ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
RNALS
1 other identifier
observational
653
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2023
Typical duration for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
July 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 18, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedMarch 27, 2026
March 1, 2026
2.4 years
June 23, 2023
March 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
SLA group
300 patients
Control group
300 patients
Interventions
During the inclusion visit : * a neurological examination is taken * a saliva sample is taken
Eligibility Criteria
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.
You may qualify if:
- 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,
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ZIWIGlead
- Monitoring Force Groupcollaborator
Study Sites (19)
CHU Strasbourg
Strasbourg, Alsace, 67098, France
CHU Nantes
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
Biospecimen
Saliva
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2023
First Posted
July 3, 2023
Study Start
July 11, 2023
Primary Completion
November 18, 2025
Study Completion
May 1, 2026
Last Updated
March 27, 2026
Record last verified: 2026-03