Genes and Environment in Multiple Sclerosis (GEMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Brigham and Women's Hospital
Sponsor:
Collaborators:
Massachusetts General Hospital
Harvard University
Information provided by (Responsible Party):
Philip De Jager, Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT01353547
First received: May 11, 2011
Last updated: February 20, 2013
Last verified: February 2013
  Purpose

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.


Condition
Multiple Sclerosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrating Genetic and Environmental Risk Scores Into an Algorithm to Predict Multiple Sclerosis Susceptibility

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 5000
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)
Groups/Cohorts
Received anti-TNFa therapy
First-degree relative of MS patients
Referred by the Partners MS Center

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01353547

Contacts
Contact: Emily K Owen, BS 617-264-5980

Locations
United States, Massachusetts
Emily Owen Recruiting
Boston, Massachusetts, United States, 02115
Contact: Emily K Owen, BS    617-264-5980    bwhmsstudy@partners.org   
Principal Investigator: Philip L De Jager, MD, PhD         
Sponsors and Collaborators
Brigham and Women's Hospital
Massachusetts General Hospital
Harvard University
Investigators
Study Director: Xongqi Xia, MD, PhD Brigham and Womens Hospital
  More Information

No publications provided

Responsible Party: Philip De Jager, Philip De Jager, M.D., Ph.D, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT01353547     History of Changes
Other Study ID Numbers: 2009p002561
Study First Received: May 11, 2011
Last Updated: February 20, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014