Relating Genetic and Environmental Risk Scores to Multiple Sclerosis Susceptibility
This study is currently recruiting participants.
Verified March 2013 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: May 1, 2013
Last verified: March 2013
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
- 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 2.5 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 Ebinger, R.N. | (301) 496-1801 | 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: | May 1, 2013 |
| 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 Genetic Predisposition to Disease 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 May 19, 2013