NCT04816227 Expression Profile Study of Macrophages From Patients Affected by ALS or Other Related Motor Impairments
| NCT ID | NCT04816227 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institut National de la Santé Et de la Recherche Médicale, France |
| Condition | Amyotrophic Lateral Sclerosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 180 participants |
| Start Date | 2021-09-29 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 180 participants in total. It began in 2021-09-29 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The aim of this project is to analyze the macrophage transcriptome and protein markers of Amyotrophic Lateral Sclerosis (ALS) patients compared to controls (non-affected individuals, patients with other motor impairments) and asymptomatic ALS gene carriers, to find new pathways for therapeutic targets and disease biomarkers.
Eligibility Criteria
Inclusion Criteria: * Agree to participate in this research and have signed an informed consent * Be able to understand the objectives and procedures of the study * Be affiliated to French social security or equivalent * Meet one of the criteria below: (i) Be affected by Amyotrophic Lateral Sclerosis (ALS) definite, probable or possible (El Escorial criteria) sporadic SALS (no known history in the family) or familial FALS (at least one other member of the family affected), (ii) not being affected by ALS but having a close relative who has or has been diagnosed with ALS and has or is a carrier of a known mutation causing ALS and has consented to a genetic analysis, (iii) Have a motor impairment including the following pathologies: Motor neuropathy, myopathy, Myositis, Spastic paraplegia, Cram / fasciculation syndrome, Chronic inflammatory polyradiculitis, somatization disorder, Anterior spinal artery syndrome, encephalitis, myelitis, Peroneal neuropathy, cervical myelopathy with radiculopathy, spinocerebellar ataxia, Kennedy disease, Spinal atrophy, Hereditary distal motor neuropathy. (iv) be accompanying a person with ALS or other motor impairment that is followed by one of the doctors from the ALS referral center at the Pitié-Salpêtrière hospital or by a neurologist from the neurophysiology department at the Pitié-Salpêtrière hospital. Exclusion Criteria: * Be subjected to a legal protection measure (safeguard of justice, curatorship or guardianship) * Refusing to participate in the study * Whose condition, in the opinion of the doctor, is incompatible with blood draw or participation in research * Being pregnant or breastfeeding
Contact & Investigator
François SALACHAS, MD
STUDY DIRECTOR
APHP, Hôpital de la Salpêtrière, INSERM U1127, ICM
Frequently Asked Questions
Who can join the NCT04816227 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Amyotrophic Lateral Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04816227 currently recruiting?
Yes, NCT04816227 is actively recruiting participants. Contact the research team at nathalie.cormand@aphp.fr for enrollment information.
Where is the NCT04816227 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04816227 clinical trial?
NCT04816227 is sponsored by Institut National de la Santé Et de la Recherche Médicale, France. The principal investigator is François SALACHAS, MD at APHP, Hôpital de la Salpêtrière, INSERM U1127, ICM. The trial plans to enroll 180 participants.
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