Relating Genetic and Environmental Risk Scores to Multiple Sclerosis Susceptibility

This study is currently recruiting participants.
Verified February 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01617395
First received: June 8, 2012
Last updated: March 14, 2014
Last verified: February 2014
  Purpose

Background:

- 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.

Objectives:

- To evaluate a score for genetic and environmental risk factors that may help predict whether a person will develop MS.

Eligibility:

  • 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.

Design:

  • 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
Multiple Sclerosis

Study Type: Observational
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 National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • The primary outcome is diagnosis of MS according to the 2010 revisions to the McDonald criteria.

Secondary Outcome Measures:
  • Secondary outcome measures include development of MS-like abnormalities on brain imaging studies, abnormalities on laboratory testing, and clinical symptoms and signs.

Estimated Enrollment: 6000
Study Start Date: April 2012
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

GEMS cohort (target n equals 1000)

  • First-degree relative (parent, sibling, or child) of a self-reported MS patient.
  • Age 18-50, inclusive, at the time of enrollment into the overall GEMS study.
  • Willingness to be contacted regarding additional follow-up procedures.
  • Cross-sectional subcohort (target n equal 100):

    • Genetic and environmental risk score (GERS) in the top or bottom 5 percent of the overall GEMS study.
  • Longitudinal subcohort (target n equal 100):

    • Ages 18-40, inclusive.
    • GERS in the top 10 percent of the overall GEMS study.
    • Willing to undergo additional study procedures at the NIH for 20 years, with planned follow-up every year for participants between ages 18 and 25, every 2 years for participants between ages 26 and 30, and every 5 years for participants between ages 31 and 40.
    • Relative enrolled in NIH study with confirmation of MS diagnosis.

MS patients

  • Co-enrolled in another Neuroimmunology Branch natural history protocol.
  • Diagnosis confirmed at NIH.
  • Age 18 or older.

Both cohorts

-Able to give informed consent.

EXCLUSION CRITERIA:

GEMS cohort

-Diagnosis of MS.

Cross-sectional and longitudinal subcohorts

  • Contraindications to MRI scanning.
  • Diagnosis of another central nervous system disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01617395

Contacts
Contact: Rosalind Hayden, R.N. (301) 827-9002 ebingerre@mail.nih.gov
Contact: Daniel S Reich, M.D. (301) 496-1801 reichds@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel S Reich, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01617395     History of Changes
Other Study ID Numbers: 120122, 12-N-0122
Study First Received: June 8, 2012
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Multiple Sclerosis
Magnetic Resonance Imaging (MRI)

Additional relevant MeSH terms:
Disease Susceptibility
Multiple Sclerosis
Sclerosis
Disease Attributes
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 April 15, 2014