A Longitudinal Analysis of Biomarkers in Patients With ALS
NCT ID: NCT05309408
Last Updated: 2023-09-22
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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UNKNOWN
90 participants
OBSERVATIONAL
2021-06-11
2024-09-30
Brief Summary
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Detailed Description
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Samples and clinical information will be collected from patients with ALS and controls. Samples will be collected from ALS subjects a maximum of 7 times over a period of up to 30 months, with approximately 3 months (and no less than 2 months) between visits. Controls will consist of participants who do not have chronic neurodegenerative diseases or diseases that mimic ALS. Up to 60 ALS subjects and 30 control subjects will be enrolled in the study.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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ALS
Patients with Amyotrophic Lateral Sclerosis (ALS)
Venipuncture
Venipuncture
Lumbar Puncture
Lumbar Puncture
Control
Participants who do not have chronic neuromuscular diseases or diseases that mimic ALS.
Venipuncture
Venipuncture
Lumbar Puncture
Lumbar Puncture
Interventions
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Venipuncture
Venipuncture
Lumbar Puncture
Lumbar Puncture
Eligibility Criteria
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Inclusion Criteria
2. Capable of providing informed consent.
3. Capable of complying with study procedures.
4. ALS Subjects only: ALS subjects diagnosed with familial or sporadic ALS as according to the El Escorial Criteria (suspected, possible, probable - lab supported, probable, or definite) or individuals with known gene mutations associated with ALS (regardless of clinical phenotype)
5. Control Subjects only: Absence of autoimmune myopathy, neuropathy, ALS mimic disorder, or any other neurodegenerative disease or known diagnosis of ALS, or known ALS causative gene
6. Lumbar Puncture volunteers only: Clinically appropriate to have a lumbar puncture
Exclusion Criteria
2. Clinically significant history of unstable medical illness
3. Inability to comply with study procedures, in the view of the investigator
4. Lumbar Puncture volunteers only: Presence of bleeding disorder, problems with cerebrospinal fluid pressure, allergy to local anesthetics, a topical or other skin infection at the lumbar puncture site
5. Lumbar Puncture volunteers only: Taking an anti-platelet or anticoagulant drug, such as Plavix, Brilinta, Ticlid, Warfarin/Coumadin, Lovenox, Elaquis, Pradaxa, Xarelto, etc, and unable to safely hold it for this study. (Aspirin is allowed)
6. Taking any immunomodulatory or immunosuppressive medication, as determined by the principal investigator.
18 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Holy Cross Hospital, Florida
OTHER
Responsible Party
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Principal Investigators
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Wilson Burke
Role: STUDY_DIRECTOR
Director
Locations
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Holy Cross Hospital
Fort Lauderdale, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HNR21-001
Identifier Type: -
Identifier Source: org_study_id
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