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Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

This study is currently recruiting participants.
Verified February 2013 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
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01396343
First received: July 14, 2011
Last updated: February 11, 2013
Last verified: February 2013
History of Changes
  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:

U.S. FDA Resources

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: November 2011
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2015 (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 12 collaborating sites other than UCSF that will enroll cases and controls for this study.

  Eligibility

Ages Eligible for Study:   up to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Case patients seen at the 13 participating Pediatric MS Center Clinics. Control patients seen at the Pediatric Clinics of the same institution as MS cases.

Criteria

Case Inclusion Criteria:

  • Patients with relapsing-remitting MS or clinically isolated symptoms (CIS) who experience disease onset before 18.
  • Children whose MRI shows at least two silent abnormal T2-bright white matter foci (one must be in the brain) and who have abnormal cerebrospinal fluid satisfy criteria for dissemination in space.
  • MS onset occurred less than 2 years prior to enrollment in study.

Case Exclusion Criteria:

  • Patients with relapsing-remitting MS or clinically isolated symptoms (CIS) who experience disease onset at 18 years or older.
  • Children whose MRI does not show at least two silent abnormal T2-bright white matter foci (one must be in the brain) and who have abnormal cerebrospinal fluid satisfy criteria for dissemination in space.
  • MS onset occurred more than 2 years prior to enrollment in study.

Control Inclusion Criteria:

  • Healthy patients that do not have MS or another autoimmune disease (except asthma or eczema).
  • Are 19 years or younger.

Control Exclusion Criteria:

  • Has an immediate, biological family member (parent/sibling) that has been diagnosed with multiple sclerosis.
  • Has a chronic neurological condition with major disability (not including migraine, uncontrolled seizures and mild learning disabilities such as ADD or ADHD).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01396343

Contacts
Contact: Janace Hart 415-514-2476 janace.hart@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         smiddleton@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         mrundquist@llu.edu    
Principal Investigator: Gregory Aaen, MD            
United States, Colorado
Children's Hospital Colorado, University of Colorado School of Medicine Recruiting
Aurora, Colorado, United States, 80045
Contact: Alexander Stein         alexander.stein@ucdenver.edu    
Contact: Alicia Camuto         alicia.camuto@childrenscolorado.org    
Principal Investigator: Teri Schreiner, MD            
United States, Illinois
Pediatric MS Clinic, Ann & Robert H. Lurie Children's Hospital of Chicago Not yet recruiting
Chicago, Illinois, United States, 60611
Contact: Lauren Webb         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: Natalie Baruch         nbaruch@partners.org    
Principal Investigator: Tanuja Chitnis, MD            
Pediatric MS Clinic, Children's Hospital Boston Recruiting
Boston, Massachusetts, United States, 02115
Contact: Susana Camposano         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         weis.delana@mayo.edu    
Principal Investigator: Moses Rodriguez, 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         mkarpinski@thejni.org    
Principal Investigator: Bianca Weinstock-Guttman, MD            
Stony Brook National Pediatric MS Center Recruiting
Stony Brook, New York, United States, 11790
Contact: Maria Milazzo         Maria.milazzo@sbumed.org    
Principal Investigator: Lauren Krupp, MD            
United States, Pennsylvania
Pediatric MS Clinic, Children's Hospital, Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Geraldine Liu         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         Samuel.hughes@UTSouthwestern.edu    
Principal Investigator: Benjamin Greenberg, MD            
MS Clinic for Pediatric Neurology at Texas Children's Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Aryn Knight         axknight@texaschildrens.org    
Principal Investigator: Timothy Lotze, 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
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: February 11, 2013
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 May 16, 2013