A Longitudinal Study of Amyotrophic Lateral Sclerosis (ALS) Biomarkers
This study is currently recruiting participants.
Verified November 2012 by Massachusetts General Hospital
Sponsor:
Massachusetts General Hospital
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: November 13, 2012
Last verified: November 2012
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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
U.S. FDA Resources
Further study details as provided by Massachusetts General Hospital:
Biospecimen Retention: Samples With DNA
Detailed 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.
| Estimated Enrollment: | 250 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
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 904-953-8946 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: Robert Lawson 617-726-0563 rjlawson@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: | November 13, 2012 |
| 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 May 22, 2013