Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 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: October 20, 2014
Last verified: October 2014

July 14, 2011
October 20, 2014
August 2010
April 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01396343 on ClinicalTrials.gov Archive Site
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Not Provided
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Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis
Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Total 41ml sample: 17ml plasma/DNA, 10ml serum, 9ml lymphocytes and 5ml RNA frozen.

Non-Probability Sample

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.

Pediatric Multiple Sclerosis
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1920
April 2016
April 2016   (final data collection date for primary outcome measure)

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).
Both
3 Years to 21 Years
Yes
Contact: Emmanuelle Waubant, MD, PhD 415-514-2468 emmanuelle.waubant@ucsf.edu
United States
 
NCT01396343
5R01NS071463
No
University of California, San Francisco
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
Principal Investigator: Emmanuelle L Waubant, MD, PhD University of California, San Francisco
University of California, San Francisco
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP