Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Collaborators:
Stony Brook University
Massachusetts General Hospital
State University of New York at Buffalo
University of Alabama at Birmingham
Mayo Clinic
Children's Hospital Philadelphia
Children's Hospital Boston
Texas Children's Hospital
Loma Linda University
Children's Hospital Colorado
University of Texas
Ann & Robert H Lurie Children's Hospital of Chicago
Washington University School of Medicine
Children's National Med Center
Primary Children's Hospital
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01396343
First received: July 14, 2011
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition
Pediatric Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Identify risk factors and their respective contribution to developing pediatric multiple sclerosis [ Time Frame: 4 year data collection, 1 year analysis ] [ Designated as safety issue: No ]
    The primary objective of this study is to determine if risk factors identified for adult MS such as HLA-DRB1*1501/1503, EBV, 25(OH) vitamin D3 insufficiency, and exposure to cigarette smoking are also risk factors for pediatric MS, and if there are interactions between them analyzing data collected from questionnaires for environmental exposure, demographic and food frequency as well as sample blood specimens.


Biospecimen Retention:   Samples With DNA

Total 35.5ml sample: 17ml plasma/DNA, 10ml serum and 8.5ml lymphocytes frozen.


Estimated Enrollment: 1920
Study Start Date: August 2010
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

The overall goal of this project is to determine whether well-established environmental and genetic risk factors for adult onset MS play an important role in susceptibility to pediatric-onset MS. Our study design is based on the hypothesis that genetic influences, specifically variation at HLA-DRB1 and other confirmed non-MHC MS loci, as well as environmental exposures including EBV infection and tobacco smoke, contribute to disease risk. In addition, we will also examine the relationship between serum levels of 25(OH) vitamin D3 and prior vitamin D status, and risk for pediatric onset MS. Finally, we will investigate whether specific G x E, and other multivariable relationships influencing risk exist for pediatric-onset MS. There are 15 collaborating sites other than UCSF that will enroll cases and controls for this study.

  Eligibility

Ages Eligible for Study:   3 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Case patients seen at the 16 participating Pediatric MS Center Clinics. Control patients seen at the Pediatric Clinics of the same institution as MS cases.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01396343

Contacts
Contact: Emmanuelle Waubant, MD, PhD 415-514-2468 emmanuelle.waubant@ucsf.edu

Locations
United States, Alabama
Center for pediatric-onset demyelinating diseases at the Children's Hospital of Alabama, Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Sarah Dowdy    205-996-7633    smdowdy@peds.uab.edu   
Principal Investigator: Jayne Ness, MD         
United States, California
Pediatric MS Clinic, Children's Hospital, Loma Linda University Recruiting
San Bernardino, California, United States, 92408
Contact: Melissa Rundquist    909-651-5058    MRundquist@llu.edu   
Principal Investigator: Gregory Aaen, MD         
UCSF Pediatric MS Center Recruiting
San Francisco, California, United States, 94143
Contact: Matthew Lee    415-514-2476    Matthew.Lee@ucsf.edu   
Principal Investigator: Emmanuelle Waubant, MD, PhD         
United States, Colorado
Children's Hospital Colorado, University of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Alexander Stein    303-724-6346    alexander.stein@ucdenver.edu   
Contact: Kathryn Connelly    303-724-3736    KATHRYN.CONNELLY@UCDENVER.EDU   
Principal Investigator: Teri Schreiner, MD         
United States, District of Columbia
Pediatric MS Clinic, Children's National Medical Center Recruiting
Washington, District of Columbia, United States, 20010
Contact: Jennifer Murphy    202-476-2120    jemurphy@cnmc.org   
Principal Investigator: Adeline Vanderver, MD         
United States, Illinois
Pediatric MS Clinic, Ann & Robert H. Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Lauren Webb    312-227-4483    lwebb@luriechildrens.org   
Principal Investigator: Jennifer Rubin, MD         
United States, Massachusetts
Partners Pediatric MS Center at the Massachusetts General Hospital for Children Recruiting
Boston, Massachusetts, United States, 02114
Contact: Chloe Fico    617-724-7860    CFICO@mgh.harvard.edu   
Principal Investigator: Tanuja Chitnis, MD         
Pediatric MS Clinic, Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Susana Camposano    857-218-4652    Susana.Camposano@childrens.harvard.edu   
Principal Investigator: Mark Gorman, MD         
United States, Minnesota
Regional Pediatric MS Center at Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Delana Weis    507-266-7196    weis.delana@mayo.edu   
Principal Investigator: Moses Rodriguez, MD         
United States, Missouri
Pediatric MS Clinic, Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: LaJune Grayson    314-454-4267    PNRC@NEURO.WUSTL.EDU   
Principal Investigator: Soe Mar, MD         
United States, New York
Pediatric MS Center of the Jacobs Neurological Institute, University of Buffalo Recruiting
Buffalo, New York, United States, 14203
Contact: Mary Karpinski    716-878-7136    mjarmeli@buffalo.edu   
Principal Investigator: Bianca Weinstock-Guttman, MD         
Stony Brook National Pediatric MS Center Recruiting
Stony Brook, New York, United States, 11790
Contact: Nneka Amadiume    631-444-7802    Nneka.Amadiume@stonybrookmedicine.edu   
Principal Investigator: Lauren Krupp, MD         
United States, Pennsylvania
Pediatric MS Clinic, Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Geraldine Liu    215-426-8336    LiuG@email.chop.edu   
Principal Investigator: Amy Waldman, MD         
United States, Texas
Pediatric MS Center, University of Texas, Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Samuel Hughes    214-645-7977    samuel.hughes@UTSouthwestern.edu   
Principal Investigator: Benjamin Greenberg, MD         
The Blue Bird Circle Clinic for MS at Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Gloria Orozco    832-822-1804    gxorozco@texaschildrens.org   
Principal Investigator: Timothy Lotze, MD         
United States, Utah
Pediatric Neurology Clinic, Primary Children's Hospital Not yet recruiting
Salt Lake City, Utah, United States, 84113
Principal Investigator: Meghan Candee, MD         
Sponsors and Collaborators
University of California, San Francisco
Stony Brook University
Massachusetts General Hospital
State University of New York at Buffalo
University of Alabama at Birmingham
Mayo Clinic
Children's Hospital Philadelphia
Children's Hospital Boston
Texas Children's Hospital
Loma Linda University
Children's Hospital Colorado
University of Texas
Ann & Robert H Lurie Children's Hospital of Chicago
Washington University School of Medicine
Children's National Med Center
Primary Children's Hospital
Investigators
Principal Investigator: Emmanuelle L Waubant, MD, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01396343     History of Changes
Other Study ID Numbers: 5R01NS071463
Study First Received: July 14, 2011
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Pediatric Multiple Sclerosis
Relapsing Remitting Multiple Sclerosis
Clinically Isolated Syndrome
Demyelinating Disease

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014