Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01396343 |
Recruitment Status :
Completed
First Posted : July 18, 2011
Last Update Posted : October 18, 2018
|
Sponsor:
University of California, San Francisco
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
Baylor College of Medicine
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
Tracking Information | ||||
---|---|---|---|---|
First Submitted Date | July 14, 2011 | |||
First Posted Date | July 18, 2011 | |||
Last Update Posted Date | October 18, 2018 | |||
Study Start Date | October 2011 | |||
Actual Primary Completion Date | April 2018 (Final data collection date for primary outcome measure) | |||
Current 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.
|
|||
Original Primary Outcome Measures | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis | |||
Official Title | Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis | |||
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. | |||
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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Control Time Perspective: Cross-Sectional |
|||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: Samples With DNA Description: Total 41ml sample: 17ml plasma/DNA, 10ml serum, 9ml lymphocytes and 5ml RNA frozen.
|
|||
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. | |||
Condition | Pediatric Multiple Sclerosis | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
|
|||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
1276 | |||
Original Estimated Enrollment |
1920 | |||
Actual Study Completion Date | April 2018 | |||
Actual Primary Completion Date | April 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Children are eligible for this study as cases if:
Patients are not eligible for study participation if:
Children are not eligible to participate as pediatric controls if:
|
|||
Sex/Gender |
|
|||
Ages | 3 Years to 21 Years (Child, Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01396343 | |||
Other Study ID Numbers | 5R01NS071463( U.S. NIH Grant/Contract ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University of California, San Francisco | |||
Study Sponsor | University of California, San Francisco | |||
Collaborators |
|
|||
Investigators |
|
|||
PRS Account | University of California, San Francisco | |||
Verification Date | October 2018 |