Relating Genetic and Environmental Risk Scores to Multiple Sclerosis Susceptibility
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|ClinicalTrials.gov Identifier: NCT01617395|
Recruitment Status : Completed
First Posted : June 12, 2012
Last Update Posted : November 5, 2020
- Research shows that both genes and the environment influence a person s risk for getting multiple sclerosis (MS). However, it is not possible to accurately predict who will develop MS. Researchers want to study people with MS and their family members. They have developed a Genetic and Environmental Risk Score for MS. This score combines information from a person's medical history and genes. It also includes environmental factors that may be related to developing MS. This study will test this risk score to see if it can help predict who will develop MS.
- To evaluate a score for genetic and environmental risk factors that may help predict whether a person will develop MS.
- Individuals at least 18 years of age who have MS.
- Individuals between 18 to 50 years of age who are the parent, brother, sister, or child of a person with MS.
- People with MS will allow researchers to look at their personal and medical data. These data will have been collected in other MS-related studies.
- Relatives of people with MS will fill out a questionnaire and give blood and saliva samples. They will fill out the questionnaire again one year later.
- Some relatives will have additional optional testing. These tests will include a physical exam and imaging studies. There may also be other tests. These tests may be repeated every 1 to 5 years for 20 years.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||181 participants|
|Official Title:||Integrating Genetic and Environmental Risk Scores Into an Algorithm to Predict Multiple Sclerosis Susceptibility|
|Actual Study Start Date :||August 15, 2012|
Individuals at risk for developing MS
Healthy Volunteer Cohort
Healthy volunteers, ages 18-50, who do not have a known first-degree relative with MS
MS Patients Cohort
MS patients whose first-degree relatives are enrolled in this study
- presence or absence of lesions on T2-weighted brain MRI [ Time Frame: ongoing ]For participants in the cross-sectional cohort, which consists of individuals at highest and lowest risk for MS, the primary outcome measure is the presence or absence of lesions on T2-weighted brain MRI that meet the 2010 MRI criteria for dissemination in space
- GERS [ Time Frame: ongoing ]For participants in the overall GEMS study, the primary outcome measure is the GERS itself, as most participants in this cohort will not undergo further testing
- development of MS-like abnormalities on brain imaging studies, abnormalities on laboratory testing, and clinical symptoms and signs. [ Time Frame: ongoing ]The age at which participants develop MS-related abnormalities on brain imaging studies, abnormalities on laboratory testing, andclinical symptoms and signs;
- The time lag between defined exposures [ Time Frame: ongoing ]time lag between defined exposures (for example, infectious mononucleosis) and the appearance of MS-related radiological, laboratory, and clinical abnormalities
- The time lag between the appearance of asymptomatic radiological and laboratory abnormalities and the onset of clinical symptoms; [ Time Frame: ongoing ]The time lag between the appearance of asymptomatic radiological and laboratory abnormalities and the onset of clinical symptoms;
- exploratory clinical, imaging, biological data in the crosssectional [ Time Frame: ongoing ]exploratory clinical, imaging, and biological data in the cross sectional that may suggest subclinical MS disease activity
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): NCT01617395
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
|Principal Investigator:||Daniel S Reich, M.D.||National Institutes of Health Clinical Center (CC)|