A Longitudinal Analysis of Biomarkers in Patients With ALS

NCT05309408 | Unknown DMC

• 1 other identifier: HNR21-001
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Longitudinally collect biomarkers from patients with amyotrophic lateral sclerosis (ALS) and control participants in order to further elucidate both potential causes and treatments for ALS. Samples and clinical information will be collected from patients with ALS and controls.

Conditions

Amyotrophic Lateral Sclerosis

Outcome Measures

Primary Outcomes (1)

• Biofluid Biorepository [ Time Frame: + 2.5 Years ]

  This project will create a biorepository of longitudinal biofluid samples, linked to clinical measures, and at home measures in order to further elucidate both potential causes and treatments for ALS.

  30 months

Study Arms (2)

ALS

Patients with Amyotrophic Lateral Sclerosis (ALS)

Diagnostic Test: Venipuncture; Diagnostic Test: Lumbar Puncture

Control

Participants who do not have chronic neuromuscular diseases or diseases that mimic ALS.

Diagnostic Test: Venipuncture; Diagnostic Test: Lumbar Puncture

Interventions

Venipuncture DIAGNOSTIC_TEST

Venipuncture

ALS; Control

Lumbar Puncture DIAGNOSTIC_TEST

Lumbar Puncture

ALS; Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

60 ALS subjects and 30 control subjects will be enrolled in the study

You may qualify if:

• years of age or older at time of consent.
• Capable of providing informed consent.
• Capable of complying with study procedures.
• 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)
• 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
• Lumbar Puncture volunteers only: Clinically appropriate to have a lumbar puncture

You may not qualify if:

• Presence of a neurodegenerative disease other than ALS
• Clinically significant history of unstable medical illness
• Inability to comply with study procedures, in the view of the investigator
• 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
• 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)
• Taking any immunomodulatory or immunosuppressive medication, as determined by the principal investigator.

Sponsors & Collaborators

• Holy Cross Hospital, Florida: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Holy Cross Hospital

Fort Lauderdale, Florida, 33308, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma, serum, whole blood, cerebrospinal fluid (CSF), urine, peripheral blood mononuclear cells (PBMC), deoxyribonucleic acid (DNA), and/or ribonucleic acid (RNA).

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Phlebotomy; Spinal Puncture

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Specimen Collection; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Biopsy; Diagnostic Techniques, Neurological

Study Officials

• Wilson Burke

  Director

  STUDY DIRECTOR

Central Study Contacts

Ashley Stepler

CONTACT

954-542-3442; ashley.stepler@holy-cross.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: April 4, 2022
• Study Start: June 11, 2021
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 22, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)