A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers

This study is currently recruiting participants. (see Contacts and Locations)
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

December 16, 2011
March 3, 2014
November 2011
December 2014   (final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT01495390 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers
A Multicenter Study for the Discovery and Validation of ALS Biomarkers

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

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.

Non-Probability Sample

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

  • Amyotrophic Lateral Sclerosis
  • Nervous System Diseases
  • Sclerosis
  • Motor Neuron Disease
  • Spinal Cord Diseases
  • Central Nervous System Diseases
  • Neurodegenerative Diseases
  • Neuromuscular Diseases
  • ALS
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Sarah Titus, MPH 617-726-1398 stitus@partners.org
United States
 
NCT01495390
BIO-ALS-02
Yes
Merit E. Cudkowicz, MD, Massachusetts General Hospital
Massachusetts General Hospital
ALS Therapy Alliance
Not Provided
Massachusetts General Hospital
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP