Validation of Biomarkers in Amyotrophic Lateral Sclerosis (ALS)
BIO_ALS-01
A Multicenter Study for the Validation of ALS Biomarkers
2 other identifiers
observational
475
2 countries
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2008
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 9, 2008
CompletedFirst Posted
Study publicly available on registry
May 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedJune 3, 2016
June 1, 2016
7.6 years
May 9, 2008
June 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ALS Functional Rating Scale (ALSFRS-R)
The ALSFRS-R is a quickly administered (5 min) ordinal rating scale used to determine a subject's assessment of their capability and independence in 12 functional activities. There are 12 questions, graded by the subject 0-4 (4 is normal). Score of 0 (worst) to 48 (best). Reflects speech and swallowing, fine motor skills, large motor skills, and breathing.
Every 6 months
Study Arms (4)
Early ALS
Suspected ALS
Disease Mimics of ALS
Healthy Controls
Interventions
Eligibility Criteria
Volunteers will be invited to participate in this study by their neurologists either in clinic or at a regular scheduled appointment visit.
You may qualify if:
- Diagnosis of possible (excluding volunteers with UMN signs ONLY), probable, probable-laboratory supported, or definite ALS, either sporadic or familial according to revised El Escorial criteria
- Disease duration of less than or equal to two years from symptom onset
- Age 30-80 years at the time of disease onset
- Ability to provide informed consent
- Ability to comply with study procedures
- Medically safe to have lumbar puncture (lumbar puncture volunteers only)
You may not qualify if:
- Clinical evidence of chronic liver or renal failure
- Presence of a bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (lumbar puncture volunteers only)
- Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (lumbar puncture volunteers only)
- Suspected ALS (PMND) Volunteers
- Diagnosis of suspected ALS defined as presence of UMN or LMN signs alone and the diagnosis of Clinically Probably Laboratory-Supported ALS CANNOT be proven by evidence in clinical grounds in conjunction with electrodiagnostic, neurophysiologic, neuroimaging or clinically laboratory studies
- Disease duration of less than or equal to four years from symptom onset
- Age 30-80 years at time of disease onset
- Ability to provide informed consent
- Ability to comply with study procedures
- Medically safe to have lumbar puncture (lumbar puncture volunteers only)
- Clinical evidence of chronic liver or renal failure
- Genetically confirmed diagnosis of hereditary spastic paraparesis or spinal motor atrophy (SMA) disease
- Presence of a bleeding disorder, problems with CSF pressure, allergy to local anesthetics, or a topical or other skin infection at the LP site (lumbar puncture volunteers only)
- Use of any anti-platelet or anticoagulant drugs, such as plavix, aggrenox, ticlid, warfarin or coumadin (lumbar puncture volunteers only)
- Neurological Disease Mimic Volunteers
- +36 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Massachusetts General Hospitallead
- ALS Associationcollaborator
- ALS Therapy Alliancecollaborator
- National Institutes of Health (NIH)collaborator
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
Study Sites (30)
Phoenix Neurological Associates, Ltd.
Phoenix, Arizona, 85018, United States
University of California Irvine
Orange, California, 92868, United States
Mayo Clinic Neurology
Jacksonville, Florida, 32224, United States
University of Miami
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Chicago
Chicago, Illinois, 60637, United States
Johns Hopkins University
Baltimore, Maryland, 21205, United States
Massachusetts General Hospital
Boston, Massachusetts, 02129, United States
Lahey Clinic
Burlington, Massachusetts, 01805, United States
Saint Mary's Healthcare
Grand Rapids, Michigan, 49503, United States
Hennepin County Medical Center
Minneapolis, Minnesota, 55404, United States
Saint Louis University
St Louis, Missouri, 63104, United States
Washington University
St Louis, Missouri, 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Robert Wood Johnson/UMDNJ
New Brunswick, New Jersey, 08901, United States
Upstate Clinical Research, LLC
Albany, New York, 12205, United States
Beth Israel Medical Center, PACC
New York, New York, 10003, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Carolinas Health Care
Charlotte, North Carolina, 28207, United States
Duke University Medical Center
Durham, North Carolina, 27705, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
OSU Medical Center
Columbus, Ohio, 43210, United States
Providence ALS Clinic
Portland, Oregon, 97213, United States
Oregon Health & Science University
Portland, Oregon, 97233, United States
Pennsylvania State University
Hershey, Pennsylvania, 17033, United States
Drexel University College of Medicine
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Methodist Neurological Institute
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84132, United States
Montreal Neurological Institute
Montreal, Quebec, H3A 2B4, Canada
Related Links
Biospecimen
650 blood samples (plasma and serum)will be collected from four groups: ALS volunteers diagnosed with ALS, volunteers with pure lower or pure upper motor neuron diseases, volunteers with other neurological diseases and healthy control volunteers. 300 cerebrospinal fluid (CSF) samples will be collected from all four groups: ALS volunteers diagnosed with ALS, volunteers with pure lower or pure upper motor neuron diseases, volunteers with other neurological diseases and healthy control volunteers. Up to 600 DNA samples will also be collected from all 4 groups: ALS volunteers diagnosed with ALS, volunteers with pure lower or pure upper motor neuron diseases, volunteers with other neurological diseases and healthy control volunteers.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James D. Berry, MD, MPH
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 9, 2008
First Posted
May 14, 2008
Study Start
April 1, 2008
Primary Completion
November 1, 2015
Study Completion
November 1, 2015
Last Updated
June 3, 2016
Record last verified: 2016-06