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Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

This study is enrolling participants by invitation only.
Sponsor:
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
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
The Cleveland Clinic
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01396343
First received: July 14, 2011
Last updated: July 17, 2017
Last verified: July 2017
  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 ]
    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 41ml sample: 17ml plasma/DNA, 10ml serum, 9ml lymphocytes and 5ml RNA frozen.

Estimated Enrollment: 1920
Study Start Date: October 2011
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 2018 (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 16 collaborating sites other than UCSF that will enroll cases and controls for this study.
  Eligibility

Ages Eligible for Study:   3 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   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.
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

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

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01396343     History of Changes
Other Study ID Numbers: 5R01NS071463 ( U.S. NIH Grant/Contract )
Study First Received: July 14, 2011
Last Updated: July 17, 2017

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

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

ClinicalTrials.gov processed this record on August 22, 2017