Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis
NCT ID: NCT01396343
Last Updated: 2018-10-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1276 participants
OBSERVATIONAL
2011-10-31
2018-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Pediatric MS Case
Demographic and Medical History Questionnaire, Environmental Exposure Questionnaire, Food Frequency Questionnaire, Blood Sample Collection
No interventions assigned to this group
Pediatric Control
Demographic and Medical History Questionnaire, Environmental Exposure Questionnaire, Food Frequency Questionnaire, Blood Sample Collection
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* MS: As defined by the 2010 McDonald criteria for diagnosis of MS (Polman 2010),
* CIS: A first demyelinating event indicating high risk for MS (i.e., one clinical event involving the spinal cord, the optic nerve, the brainstem or cerebellum, or occasionally the hemispheres) and at least 2 silent T2 bright areas on a brain or spinal cord MRI (at least one must be in the brain); AND
* They are three years of age or older; AND
* Disease onset occurred before 18 years of age.
Patients are not eligible for study participation if:
* Disease onset occurred more than 4 years prior to the opportunity to enroll; OR
* They have had an organ transplant; OR
* They are known to have neuromyelitis optica (NMO).
Children are not eligible to participate as pediatric controls if:
* They are two years of age or younger; OR
* They are 22 years of age or older; OR
* They are known to have MS or another demyelinating disease (for example, neuromyelitis optica or acute disseminated encephalomyelitis); OR
* They have a biological family member who has been enrolled as a control; OR
* They have an immediate, biological family member (parent/sibling) who has been diagnosed with MS; OR
* They have an autoimmune disorder (except asthma or eczema); OR
* They have had an organ transplant; OR
* They have a chronic neurological condition with major disability (this does not include, for example, migraine, controlled seizures, and mild learning disabilities such as ADD or ADHD).
3 Years
21 Years
ALL
Yes
Sponsors
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New York University
OTHER
Massachusetts General Hospital
OTHER
State University of New York at Buffalo
OTHER
University of Alabama at Birmingham
OTHER
Mayo Clinic
OTHER
Children's Hospital of Philadelphia
OTHER
Boston Children's Hospital
OTHER
Baylor College of Medicine
OTHER
Loma Linda University
OTHER
Children's Hospital Colorado
OTHER
University of Texas
OTHER
Ann & Robert H Lurie Children's Hospital of Chicago
OTHER
Washington University School of Medicine
OTHER
Children's National Research Institute
OTHER
Primary Children's Hospital
OTHER
The Cleveland Clinic
OTHER
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Emmanuelle L Waubant, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Center for pediatric-onset demyelinating diseases at the Children's Hospital of Alabama, Birmingham
Birmingham, Alabama, United States
Pediatric MS Clinic, Children's Hospital, Loma Linda University
San Bernardino, California, United States
UCSF Pediatric MS Center
San Francisco, California, United States
Children's Hospital Colorado, University of Colorado School of Medicine
Aurora, Colorado, United States
Pediatric MS Clinic, Children's National Medical Center
Washington D.C., District of Columbia, United States
Pediatric MS Clinic, Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Partners Pediatric MS Center at the Massachusetts General Hospital for Children
Boston, Massachusetts, United States
Pediatric MS Clinic, Children's Hospital Boston
Boston, Massachusetts, United States
Regional Pediatric MS Center at Mayo Clinic
Rochester, Minnesota, United States
Pediatric MS Clinic, Washington University School of Medicine
St Louis, Missouri, United States
Pediatric MS Center of the Jacobs Neurological Institute, University of Buffalo
Buffalo, New York, United States
New York University Langone Medical Center
New York, New York, United States
The Cleveland Clinic
Cleveland, Ohio, United States
Pediatric MS Clinic, Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Pediatric MS Center, University of Texas, Southwestern Medical Center
Dallas, Texas, United States
The Blue Bird Circle Clinic for MS at Texas Children's Hospital
Houston, Texas, United States
Pediatric Neurology Clinic, Primary Children's Hospital
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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