Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis

NCT01396343 | Completed DMC

• 1 other identifier: 5R01NS071463
• Study Type: observational
• Target: 1,276
• Locations: 1 country
• Sites: 17

Brief 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.

Conditions

Pediatric Multiple Sclerosis

Keywords

Pediatric Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis; Clinically Isolated Syndrome; Demyelinating Disease

Outcome Measures

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.

  4 year data collection, 1 year analysis

Study Arms (2)

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

Eligibility Criteria

• Age: 3 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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.

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• New York University: collaborator
• Massachusetts General Hospital: collaborator
• State University of New York at Buffalo: collaborator
• University of Alabama at Birmingham: collaborator
• Mayo Clinic: collaborator
• Children's Hospital of Philadelphia: collaborator
• Boston Children's Hospital: collaborator
• Baylor College of Medicine: collaborator
• Loma Linda University: collaborator
• Children's Hospital Colorado: collaborator
• University of Texas: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Washington University School of Medicine: collaborator
• Children's National Research Institute: collaborator
• Primary Children's Hospital: collaborator
• The Cleveland Clinic: collaborator

Study Sites (17)

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

Birmingham, Alabama, 35294, United States

Location

Pediatric MS Clinic, Children's Hospital, Loma Linda University

San Bernardino, California, 92408, United States

Location

UCSF Pediatric MS Center

San Francisco, California, 94143, United States

Location

Children's Hospital Colorado, University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Pediatric MS Clinic, Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Pediatric MS Clinic, Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Partners Pediatric MS Center at the Massachusetts General Hospital for Children

Boston, Massachusetts, 02114, United States

Location

Pediatric MS Clinic, Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

Regional Pediatric MS Center at Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Pediatric MS Clinic, Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Pediatric MS Center of the Jacobs Neurological Institute, University of Buffalo

Buffalo, New York, 14203, United States

Location

New York University Langone Medical Center

New York, New York, 10016, United States

Location

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Pediatric MS Clinic, Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Pediatric MS Center, University of Texas, Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

The Blue Bird Circle Clinic for MS at Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Pediatric Neurology Clinic, Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Demyelinating Diseases

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Emmanuelle L Waubant, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2011
• First Posted: July 18, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

US (17)