Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

University of California, San Francisco1,276 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,276

Conditions

Pediatric Multiple Sclerosis

Eligibility

Sex: ALLMin age: 3 YearsMax age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (17)

Center for pediatric-onset demyelinating diseases at the Children's Hospital of Alabama, Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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