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Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS) (BIO_ALS-01)

 
Study Focus:
The purpose of this study is to collect biofluid samples for the banking and usage in ALS research.
Disease:
Amyotrophic Lateral Sclerosis (ALS), Sporadic ALS, Familial ALS, Primary Lateral Sclerosis (PLS), Hereditary Spastic Paraplegia (HSP), Healthy Volunteer, Other: Disease Mimics of ALS
Study Category:
Biomarkers/imaging
Study Status:
Active, no longer recruiting
Phase:
Not Applicable
Type:
Observational Study
Funding Source:
ALSA, ATA, NIH
Study Chair(s)/Principal Investigator(s):
Merit Cudkowicz, MD, MSc (Massachusetts General Hospital)
James D. Berry, MD, PhD (Massachusetts General Hospital)
Robert Bowser, PhD (Barrow Neurological Institute)
Clinicaltrials.gov ID:
NCT00677768
Study ID:
BIO_ALS-01
NEALS Affiliated?
Yes
Study Summary:
The purpose of this study is to collect 650 blood and 300 cerebrospinal fluid (CSF) samples from people with amyotrophic lateral sclerosis (ALS), pure lower or upper motor neuron diseases, as well as other neurodegenerative diseases and from people with no neurological disorder. 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 diagnose ALS and monitor disease progression.

Additionally, up to 600 blood samples will be collected for a sub-study for DNA analysis. Studying components of the blood, such as DNA, may help us understand what happens when genes function abnormally and how it might be related to disease.
Participant Duration:
Up to 36 months
# of Subjects:
650
Enrollment Start Date:
05/01/2008
Enrollment End Date:
12/01/-0001
Posting Last Modified Date:
12/01/2011
Date Study Added to alsconsortium.org:
11/01/2011
More information:
Researchers tested what changes happen in volunteers with ALS that can be seen in the blood and what changes are unique to ALS and are different from those found in healthy volunteers and volunteers with neurological diseases other than ALS. These changes are called biomarkers. Biomarkers for ALS have been found in blood collected in earlier phases of this study. Biomarkers are non-genetic elements in your blood that may help to make diagnosing ALS easier. In the next phase, comparison of these changes in the blood of volunteers with ALS and without ALS will be used to confirm these biomarkers and to develop a tool to diagnose and monitor progression of ALS.
Eligibility Criteria
Gender:
Male & Female
Minimum Age:
30
Maximum Age:
80
Min Vital Capacity (% predicted normal):
N/A
Time since Symptom Onset:
Less than 36 months
Can participants use Riluzole?
Yes
Coordinating Center
Contact Information
Daniela Grasso
dgrasso@partners.org
617-726-0842
NCRI at the Massachusetts General Hospital
149 13th Street, BLDG 149, MGH East
Boston, Massachusetts 02129
UNITED STATES
Other Eligibility Criteria:
Medically safe to have lumbar puncture

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