A Longitudinal Analysis of Biomarkers in Patients With ALS (LAB-PALS)

September 21, 2023 updated by: Holy Cross Hospital, Florida
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of the proposed study is to 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. The investigators will collect blood or any of the following biofluids: blood, urine, and cerebrospinal fluid (CSF), and process, analyze and store plasma, serum, whole blood, cerebrospinal fluid (CSF), urine, peripheral blood mononuclear cells (PBMC), deoxyribonucleic acid (DNA), and/or ribonucleic acid (RNA). Blood collected in this study may also potentially be used to create induced pluripotent stem cells (iPSCs). Excess samples will be stored in a repository at Massachusetts General Hospital ALS Sample Repository for future research on ALS and related motor neuron diseases. Planned analyses may include but will not be limited to: exploring immune cell populations, gene expression profiling, and analysis or metabolites, proteins, RNA, DNA obtained from blood and/or exploring associated clinical parameters. Analyses will explore the differences of these factors between ALS and control subjects.

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.

Study Type

Observational

Enrollment (Estimated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Hospital
        • Contact:
        • Principal Investigator:
          • Gustavo Alameda, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  1. 18 years of age or older at time of consent.
  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:

  1. Presence of a neurodegenerative disease other than ALS
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ALS
Patients with Amyotrophic Lateral Sclerosis (ALS)
Diagnostic test: Venipuncture
Venipuncture
Diagnostic test: Lumbar Puncture
Lumbar Puncture
Control
Participants who do not have chronic neuromuscular diseases or diseases that mimic ALS.
Diagnostic test: Venipuncture
Venipuncture
Diagnostic test: Lumbar Puncture
Lumbar Puncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biofluid Biorepository [ Time Frame: + 2.5 Years ]
Time Frame: 30 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Holy Cross Hospital, Florida

Collaborators

Massachusetts General Hospital

Investigators

  • Study Director: Wilson Burke, Director

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2021

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 20, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (Actual)

April 4, 2022

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 21, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNR21-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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