Pediatric Multiple SclerosisNCT01396343
Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis
An observational study of Pediatric Multiple Sclerosis, run by University of California, San Francisco at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Multiple Sclerosis
- How many people
- 1,276 participants
- Where
- 17 sitesUnited States
- Study dates
- Oct 2011to Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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).
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Children's Hospital Colorado, University of Colorado School of Medicine
Aurora, Colorado, 80045
Center for pediatric-onset demyelinating diseases at the Children's Hospital of Alabama, Birmingham
Birmingham, Alabama, 35294
Partners Pediatric MS Center at the Massachusetts General Hospital for Children
Boston, Massachusetts, 02114
Pediatric MS Clinic, Children's Hospital Boston
Boston, Massachusetts, 02115
Pediatric MS Center of the Jacobs Neurological Institute, University of Buffalo
Buffalo, New York, 14203
Pediatric MS Clinic, Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
The Cleveland Clinic
Cleveland, Ohio, 44195
Pediatric MS Center, University of Texas, Southwestern Medical Center
Dallas, Texas, 75390
The Blue Bird Circle Clinic for MS at Texas Children's Hospital
Houston, Texas, 77030
New York University Langone Medical Center
New York, New York, 10016
Pediatric MS Clinic, Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Regional Pediatric MS Center at Mayo Clinic
Rochester, Minnesota, 55905
Pediatric Neurology Clinic, Primary Children's Hospital
Salt Lake City, Utah, 84113
Pediatric MS Clinic, Children's Hospital, Loma Linda University
San Bernardino, California, 92408
UCSF Pediatric MS Center
San Francisco, California, 94143
Pediatric MS Clinic, Washington University School of Medicine
St Louis, Missouri, 63110
Pediatric MS Clinic, Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
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.
Read the 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.
- Conditions
- Pediatric Multiple Sclerosis
- Keywords
- Pediatric Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Clinically Isolated Syndrome, Demyelinating Disease
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Demyelinating Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 year data collection, 1 year analysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2011 (estimated)
- Study startOct 2011
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,276 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- 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 Research Institute, Primary Children's Hospital, The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Emmanuelle L Waubant, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396343
- Sponsor's protocol ID
- 5R01NS071463
- Status last verified
- Oct 2018
- First submitted
- 14 Jul 2011
- Last updated
- 18 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental and Genetic Risk Factors for Pediatric Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT01396343
- Acronym / sponsor ID
- 5R01NS071463
- Conditions
- Pediatric Multiple Sclerosis
- Keywords
- Pediatric Multiple Sclerosis, Relapsing Remitting Multiple Sclerosis, Clinically Isolated Syndrome, Demyelinating Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,276 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- 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 Research Institute, Primary Children's Hospital, The Cleveland Clinic
- Study start
- Oct 2011
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 18 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle L Waubant, MD, PhD principal investigator
University of California, San Francisco
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Multiple Sclerosis, run by University of California, San Francisco at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify risk factors and their respective contribution to developing pediatric multiple sclerosis (time frame: 4 year data collection, 1 year analysis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.