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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06450691
Other study ID # APHP231795
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2024
Est. completion date September 2033

Study information

Verified date June 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Maria del Mar Amador, MD
Phone 33142162472
Email mariadelmar.amador@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease in adults. This longitudinal study involves three cohorts of participants: patients with sporadic or hereditary ALS, asymptomatic individuals carrying pathogenic mutations responsible for ALS, and control subjects. In this study, a skin biopsy and blood sampling will be performed at the initial visit (M0), then at M12 (+/- 2 months) for patients, and at M36 (+/- 12 months) for asymptomatic carriers of pathogenic mutations. The aim of this research is to model ALS pathology using fibroblasts derived from the patients' skin biopsies.


Description:

Amyotrophic Lateral Sclerosis (ALS) is the most common motor neuron disease in adults. This longitudinal study involves three cohorts of participants: patients with sporadic or hereditary ALS, asymptomatic individuals carrying pathogenic mutations responsible for ALS, and control subjects. In this study, a skin biopsy and blood sampling will be performed at the initial visit (M0), then at M12 (+/- 2 months) for patients, and at M36 (+/- 12 months) for asymptomatic carriers of pathogenic mutations. The aim of this research is to model ALS pathology using fibroblasts derived from the patients' skin biopsies.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 110
Est. completion date September 2033
Est. primary completion date September 2033
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria common to all 3 populations: - adults, both sexes - with written consent to participate in the study - affiliated to a social security scheme ALS patients : - patients with ALS according to the revised El Escorial criteria : - with a hereditary form of ALS, defined by the presence of a family history of ALS or by the demonstration of a pathogenic mutation in the patient or - with a juvenile form of the disease, defined by onset of symptoms at less than 30 years of age or - with a sporadic form of ALS Asymptomatic mutation carriers : - Asymptomatic individuals who carry a mutation causing ALS but have not developed symptoms. Healthy subjects: - control individuals, taking into account male/female and close age matching Exclusion Criteria: - with a known skin disease (acne, atopic dermatitis, psoriasis, melanoma, skin carcinoma, rosacea, scabies; as referenced on http://dermato-info.fr/), which in the investigator's opinion constitutes a contraindication to skin biopsy - have a platelet count of less than 75,000/mm3 in a laboratory test less than 3 months old, - with a proven allergy to lidocaine or prilocaine, - Pregnant or breast-feeding women, or subjects under guardianship, curatorship or safeguard of justice. - Patient's condition which, in the opinion of the investigator, is incompatible with skin sampling or participation in the study. - Participation in a clinical trial (involving a drug) or other interventional research if this interferes with FIBRALS research.

Study Design


Intervention

Procedure:
biopsy
skin biopsy and blood sampling

Locations

Country Name City State
France CIC Neurosciences Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary fibroblasts immunofluorescence analysis. Detection of cytoplasmic TDP-43, TIA1 and/or p62 aggregates in patient fibroblasts subjected to various cellular stresses by immunofluorescence analysis. 1 year
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