Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

Status: Completed
Location: See all (17) locations...
Study Type: Observational
SUMMARY

The purpose of this study is to better understand multiple sclerosis (MS) in children and adolescents, to learn if it differs from adult MS and to investigate if genes or environmental exposures or a combination of both put children and adolescents at risk for getting MS.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 21
Healthy Volunteers: Accepts Healthy Volunteers
View:

• Children are eligible for this study as cases if:

• They have MS or clinically isolated syndrome (CIS):

• 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).

Locations
United States
Alabama
Center for pediatric-onset demyelinating diseases at the Children's Hospital of Alabama, Birmingham
Birmingham
California
Pediatric MS Clinic, Children's Hospital, Loma Linda University
San Bernardino
UCSF Pediatric MS Center
San Francisco
Colorado
Children's Hospital Colorado, University of Colorado School of Medicine
Aurora
Washington, D.c.
Pediatric MS Clinic, Children's National Medical Center
Washington
Illinois
Pediatric MS Clinic, Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago
Massachusetts
Partners Pediatric MS Center at the Massachusetts General Hospital for Children
Boston
Pediatric MS Clinic, Children's Hospital Boston
Boston
Minnesota
Regional Pediatric MS Center at Mayo Clinic
Rochester
Missouri
Pediatric MS Clinic, Washington University School of Medicine
Saint Louis
New York
Pediatric MS Center of the Jacobs Neurological Institute, University of Buffalo
Buffalo
New York University Langone Medical Center
New York
Ohio
The Cleveland Clinic
Cleveland
Pennsylvania
Pediatric MS Clinic, Children's Hospital of Philadelphia
Philadelphia
Texas
Pediatric MS Center, University of Texas, Southwestern Medical Center
Dallas
The Blue Bird Circle Clinic for MS at Texas Children's Hospital
Houston
Utah
Pediatric Neurology Clinic, Primary Children's Hospital
Salt Lake City
Time Frame
Start Date: October 2011
Completion Date: April 2018
Participants
Target number of participants: 1276
Treatments
Pediatric MS Case
Demographic and Medical History Questionnaire, Environmental Exposure Questionnaire, Food Frequency Questionnaire, Blood Sample Collection
Pediatric Control
Demographic and Medical History Questionnaire, Environmental Exposure Questionnaire, Food Frequency Questionnaire, Blood Sample Collection
Authors
Teri Schreiner, Tanuja Chitnis, Gregory Aaen, Meghan Candee, Lauren Krupp, Jennifer Rubin, Benjamin Greenberg, Timothy Lotze, Mark Gorman, Mary Rensel, Moses Rodriguez, Soe Mar, Ilana Kahn, Jayne Ness, Emmanuelle L Waubant, Amy Waldman, Bianca Weinstock-Guttman
Related Therapeutic Areas
Sponsors
Collaborators: Children's Hospital Colorado, Primary Children's Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, Baylor College of Medicine, Loma Linda University, University of Texas, Washington University School of Medicine, State University of New York at Buffalo, Mayo Clinic, Children's Hospital of Philadelphia, Children's National Med Center, Massachusetts General Hospital, New York University, University of Alabama at Birmingham, The Cleveland Clinic, Boston Children's Hospital
Leads: University of California, San Francisco

This content was sourced from clinicaltrials.gov

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