CClinicalTrials.gg
CompletedNCT01396343Updated Oct 18, 2018

Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

An observational study in Pediatric Multiple Sclerosis, sponsored by University of California, San Francisco. Completed at 17 sites in United States. Open to participants aged 3 Years to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-18.

Sponsored by University of California, San Francisco · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,276
Ages
3 Years to 21 Years
Sex
All
01

Study 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.

Read the 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 16 collaborating sites other than UCSF that will enroll cases and controls for this study.

02

Conditions studied

  • Pediatric Multiple Sclerosis

Keywords

  • Pediatric Multiple Sclerosis
  • Relapsing Remitting Multiple Sclerosis
  • Clinically Isolated Syndrome
  • Demyelinating Disease
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 1,276 is above the median of 100 across 1,016 observational studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.

Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 21 Years
Sexes eligible
All
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.

Eligibility 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).
05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,276 participants (actual)
Biospecimen retention
Samples with dna

Groups and 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

06

What researchers measure

Primary outcomes

  1. Identify risk factors and their respective contribution to developing pediatric multiple sclerosis

    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.

    Time frame: 4 year data collection, 1 year analysis

07

Study locations

17 sites
  • Center for pediatric-onset demyelinating diseases at the Children's Hospital of Alabama, Birmingham
    Birmingham, Alabama 35294, United States
  • Pediatric MS Clinic, Children's Hospital, Loma Linda University
    San Bernardino, California 92408, United States
  • UCSF Pediatric MS Center
    San Francisco, California 94143, United States
  • Children's Hospital Colorado, University of Colorado School of Medicine
    Aurora, Colorado 80045, United States
  • Pediatric MS Clinic, Children's National Medical Center
    Washington, District of Columbia 20010, United States
  • Pediatric MS Clinic, Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
  • Partners Pediatric MS Center at the Massachusetts General Hospital for Children
    Boston, Massachusetts 02114, United States
  • Pediatric MS Clinic, Children's Hospital Boston
    Boston, Massachusetts 02115, United States
  • Regional Pediatric MS Center at Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Pediatric MS Clinic, Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
  • Pediatric MS Center of the Jacobs Neurological Institute, University of Buffalo
    Buffalo, New York 14203, United States
  • New York University Langone Medical Center
    New York, New York 10016, United States
  • The Cleveland Clinic
    Cleveland, Ohio 44195, United States
  • Pediatric MS Clinic, Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
  • Pediatric MS Center, University of Texas, Southwestern Medical Center
    Dallas, Texas 75390, United States
  • The Blue Bird Circle Clinic for MS at Texas Children's Hospital
    Houston, Texas 77030, United States
  • Pediatric Neurology Clinic, Primary Children's Hospital
    Salt Lake City, Utah 84113, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 18, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01396343
Lead sponsor
University of California, San Francisco
Collaborators
New York University, Massachusetts General Hospital, State University of New York at Buffalo, University of Alabama at Birmingham, Mayo Clinic, Children's Hospital of Philadelphia, Boston Children's Hospital, Baylor College of Medicine, 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, The Cleveland Clinic
Responsible party
Sponsor
First posted
Jul 18, 2011
Start date
Oct 2011
Primary completion
Apr 2018
Completion
Apr 2018
Last update
Oct 18, 2018

Study contacts

Emmanuelle L Waubant, MD, PhD
principal investigator · University of California, San Francisco

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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