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Genes and Environment in Multiple Sclerosis (GEMS)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01353547
Recruitment Status : Recruiting
First Posted : May 13, 2011
Last Update Posted : January 28, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

May 11, 2011
May 13, 2011
January 28, 2016
March 2010
March 2018   (Final data collection date for primary outcome measure)
Brain MRI after recruiting 2200 subjects and calculating their genetic and environmental risk score of Multiple Sclerosis. [ Time Frame: 5 years ]
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.
Same as current
Complete list of historical versions of study NCT01353547 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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Genes and Environment in Multiple Sclerosis
Integrating Genetic and Environmental Risk Scores Into an Algorithm to Predict Multiple Sclerosis Susceptibility
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Saliva Sample (required), Blood Sample (optional)
Probability Sample
This large research study will ultimately enroll over 5000 subjects who are at risk of developing MS. The study will last 20 years. We will recruit subjects from all over the United States, as everything is done via mail, email, or/and phone.
Multiple Sclerosis
Not Provided
  • Received anti-TNFa therapy
    Received anti-TNFa therapy
  • First-degree relative of MS patients
    First-degree relative (child, parent or sibling) of a diagnosed MS patient
  • Referred by the Partners MS Center
    Referred by the Partners MS Center
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
March 2020
March 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • First Degree Relatives of Patients with MS, or
  • Patients who have received anti-TNFa therapy as treatment for inflammatory diseases other than MS such as Crohn's disease, psoriasis and rheumatoid arthritis, or
  • Patients that have been referred for an evaluation of first presentation of neurologic symptoms but do not have a diagnosis of MS
  • Live in the United States

Exclusion Criteria:

  • Does not match any of the inclusion criteria
Sexes Eligible for Study: All
18 Years to 50 Years   (Adult)
Yes
Contact: GEMS Coordinator, BS 617-264-5980 bwhmsstudy@partners.org
United States
 
 
NCT01353547
2009p002561
Yes
Not Provided
Not Provided
Philip De Jager, Brigham and Women's Hospital
Brigham and Women's Hospital
  • Massachusetts General Hospital
  • Harvard Medical School
  • National Institutes of Health (NIH)
Study Director: Xongqi Xia, MD, PhD Brigham and Womens Hospital
Brigham and Women's Hospital
January 2016