Trial record 1 of 1 for:
NCT01396343
Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis
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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 |
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Recruitment Status :
Completed
First Posted : July 18, 2011
Last Update Posted : October 18, 2018
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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
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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.
| Condition or disease |
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| Pediatric Multiple Sclerosis |
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 |
| Actual Enrollment : | 1276 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | April 2018 |
| Actual Study Completion Date : | April 2018 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
| Group/Cohort |
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Pediatric MS Case
Demographic and Medical History Questionnaire, Environmental Exposure Questionnaire, Food Frequency Questionnaire, Blood Sample Collection
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Pediatric Control
Demographic and Medical History Questionnaire, Environmental Exposure Questionnaire, Food Frequency Questionnaire, Blood Sample Collection
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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.
Information from the National Library of Medicine
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| 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:
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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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01396343
Locations
Show 17 study locations
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
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
Investigators
| Principal Investigator: | Emmanuelle L Waubant, MD, PhD | University of California, San Francisco |
| Responsible Party: | University of California, San Francisco |
| ClinicalTrials.gov Identifier: | NCT01396343 |
| Other Study ID Numbers: |
5R01NS071463 ( U.S. NIH Grant/Contract ) |
| First Posted: | July 18, 2011 Key Record Dates |
| Last Update Posted: | October 18, 2018 |
| Last Verified: | October 2018 |
Keywords provided by University of California, San Francisco:
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Pediatric Multiple Sclerosis Relapsing Remitting Multiple Sclerosis Clinically Isolated Syndrome Demyelinating Disease |
Additional relevant MeSH terms:
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Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |