ALS Diagnosis From a Saliva Sample: a Non-coding RNA Analysis Approach
NCT ID: NCT05928416
Last Updated: 2024-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2023-07-11
2025-07-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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SLA group
300 patients
Saliva sample
During the inclusion visit :
* a saliva sample is taken
Control group
300 patients
Saliva sample
During the inclusion visit :
* a neurological examination is taken
* a saliva sample is taken
Interventions
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Saliva sample
During the inclusion visit :
* a neurological examination is taken
* a saliva sample is taken
Saliva sample
During the inclusion visit :
* a saliva sample is taken
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
ALL
Yes
Sponsors
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Monitoring Force Group
INDUSTRY
ZIWIG
INDUSTRY
Responsible Party
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Locations
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CHU Strasbourg
Strasbourg, Alsace, France
CHU Nantes
Saint-Herblain, Loire-Atlantique, France
C.H.U. de Saint-Étienne
Saint-Étienne-de-Montluc, Pays de la Loire Region, France
Hospices Civils de Lyon
Bron, Rhône, France
CHU Angers
Angers, , France
CHU Bordeaux
Bordeaux, , France
Hôpital Cavale Blanche
Brest, , France
CHU Caen
Caen, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
CHRU Lille
Lille, , France
CHU Dupuytren
Limoges, , France
Hôpital de La Timone
Marseille, , France
CHU Montpellier
Montpellier, , France
CHU Nice
Nice, , France
Hôpital de la Pitié-Salpêtrière
Paris, , France
CHU Rennes
Rennes, , France
CHU de la Réunion
Saint-Pierre, , France
CHU Toulouse
Toulouse, , France
CHU Bretonneau
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023-01
Identifier Type: -
Identifier Source: org_study_id
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