A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

This study is currently recruiting participants.
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Collaborator:
ALS Therapy Alliance
Information provided by (Responsible Party):
Merit E. Cudkowicz, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01495390
First received: December 16, 2011
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

The purpose of this study is to collect biofluid samples for the banking and usage in ALS research. Through comparison of these samples, the researchers hope to learn more about the underlying cause of ALS, as well as find unique biological markers, which could be used to develop new therapies.


Condition
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Sclerosis
Motor Neuron Disease
Spinal Cord Diseases
Central Nervous System Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
ALS

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multicenter Study for the Discovery and Validation of ALS Biomarkers

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Biospecimen Retention:   Samples With DNA

Biological samples will be collected from participants with ALS over time. These biological samples include blood (plasma, serum, and RNA) and cerebrospinal fluid (CSF). DNA will be collected at one time point.


Estimated Enrollment: 250
Study Start Date: November 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Detailed Description:

The purpose of the research study is to collect blood samples and cerebrospinal fluid (CSF) from people with amyotrophic lateral sclerosis (ALS). These samples will be collected approximately every 4 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Volunteers will be invited to participate in this study by their neurologists either in clinic or at a regular scheduled appointment visit

Criteria

Inclusion Criteria:

  • Age 18 or older
  • Diagnosis of suspected, possible, probable or definite ALS according to El Escorial Criteria
  • Vital capacity (VC) at least 50 percent predicted
  • Able to undergo multiple lumbar punctures

Exclusion Criteria:

  • Abnormal CSF pressure or intracranial/intraspinal tumors
  • Use of anticoagulant medication that cannot be safely withheld
  • Bleeding disorders

    • This is a partial listing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495390

Contacts
Contact: Sarah Titus, MPH 617-726-1398 stitus@partners.org

Locations
United States, Arizona
Barrow Neurological Institute Recruiting
Phoenix, Arizona, United States, 85013
Contact: Gale Kittle, RN, MPH    602-406-4792    Gale.Kittle@DignityHealth.org   
Principal Investigator: Shafeeq Ladha, MD         
United States, Florida
Mayo Clinic Jacksonville Recruiting
Jacksonville, Florida, United States, 32224
Contact: Karen Overstreet    904-953-6523    overstreet.karen@mayo.edu   
Principal Investigator: Kevin Boylan, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Latoya Shaw    404-727-1673    Latoya.q.shaw@emory.edu   
Principal Investigator: Jonathan Glass, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Christina Dheel    617-643-6252    cdheel@partners.org   
Principal Investigator: James Berry, MD, MPH         
University of Massachusetts Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Diane McKenna-Yasek    508-856-4697    diane.mckenna-yasek@umassmed.edu   
Principal Investigator: Robert Brown, MD, DPhil         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Danielle Rowlands, RN    412-648-9053    doerdx@UPMC.EDU   
Principal Investigator: David Lacomis, MD         
Sponsors and Collaborators
Massachusetts General Hospital
ALS Therapy Alliance
  More Information

Additional Information:
No publications provided

Responsible Party: Merit E. Cudkowicz, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01495390     History of Changes
Other Study ID Numbers: BIO-ALS-02
Study First Received: December 16, 2011
Last Updated: March 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Biomarkers
Biological Markers
Surrogate Markers
Clinical Markers
Plasma
Cerebrospinal Fluid
DNA
Serum
RNA

Additional relevant MeSH terms:
Neurodegenerative Diseases
Amyotrophic Lateral Sclerosis
Central Nervous System Diseases
Nervous System Diseases
Neuromuscular Diseases
Sclerosis
Spinal Cord Diseases
Motor Neuron Disease
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014