Genes and Environment in Multiple Sclerosis (GEMS)
Recruitment status was Recruiting
The purpose of the research study is to identify the genetic, environmental and immune profiles that may increase a person's risk of developing multiple sclerosis (MS). While MS is not a disease caused by a single variation in genetic material (DNA), a single environmental factor, or a single malfunction in immune cells, there are genetic alterations, environmental exposures and immunologic factors that make the development of MS more likely. Obtaining information about who is at risk for MS will be beneficial in the future if the investigators can identify effective ways to prevent or slow down the progression of this disease.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Integrating Genetic and Environmental Risk Scores Into an Algorithm to Predict Multiple Sclerosis Susceptibility|
- Brain MRI after recruiting 2200 subjects and calculating their genetic and environmental risk score of Multiple Sclerosis. [ Time Frame: 5 years ] [ Designated as safety issue: No ]Genetic and Environmental Risk Score (GERS) will be calculated based on answers given in subject questionnaire and DNA collected from saliva sample. The questionnaire is about their neurologic and family history and potential environmental exposures. Subjects with the top and bottom 10% of GERS will undergo a single draw of up to 120 cc blood for analysis of immunologic markers. Subjects with the top and bottom 2.5% of GERS will undergo brain MRI to assess for asymptomatic MS-like lesions.
Biospecimen Retention: Samples With DNA
Saliva Sample (required), Blood Sample (optional)
|Study Start Date:||March 2010|
|Estimated Study Completion Date:||March 2014|
|Estimated Primary Completion Date:||March 2014 (Final data collection date for primary outcome measure)|
|Received anti-TNFa therapy|
|First-degree relative of MS patients|
|Referred by the Partners MS Center|
MS is an autoimmune disease in which the immune system (white bloods cells that normally fight infection) becomes misdirected and attacks healthy tissue. In patients with MS, the misdirected white blood cells attack myelin, a lining that insulates the nerves found in your brain and spinal cord. This results in inflammation and damage in the myelin. Loss of this protective lining disrupts nerve impulses and causes abnormal function in the nervous system.
This large research study will ultimately enroll over 5000 subjects who are at risk of developing MS.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01353547
|Contact: Emily K Owen, BS||617-264-5980|
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02115|
|Contact: Emily K Owen, BS 617-264-5980 firstname.lastname@example.org|
|Principal Investigator: Philip L De Jager, MD, PhD|
|Study Director:||Xongqi Xia, MD, PhD||Brigham and Womens Hospital|