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

History of Changes

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:

Genetics Home Reference related topics: amyotrophic lateral sclerosis

MedlinePlus related topics: Amyotrophic Lateral Sclerosis Degenerative Nerve Diseases Neurologic Diseases Neuromuscular Disorders Spinal Cord Diseases

Genetic and Rare Diseases Information Center resources: Amyotrophic Lateral Sclerosis

U.S. FDA Resources

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:

Northeast ALS Consortium Website This link exits the ClinicalTrials.gov site

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:


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

ClinicalTrials.gov processed this record on February 26, 2015

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