Risk Factors in Early Multiple Sclerosis

NCT03586986 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2023-02-06

No results posted yet for this study

Summary

The central hypothesis of this protocol is that it is possible, using First Degree Relatives (FDRs) of patients with Multiple Sclerosis (MS) and assessing a variety of both known and unknown risk factors for MS, to define a risk algorithm for earliest signs of development of MS. The plan will be to do an abbreviated brain Magnetic Resonance Imaging (MRI) scan in asymptomatic, young FDRs, analyze blood for a variety of immunological, genetic, neuroaxonal damage, metabolic, viral serology and other markers, and have FDRs fill out a detailed bioscreen questionnaire about lifestyle factors and perform a cognitive screening test. The investigators will then compare the results of the various blood/other studies in FDRs with and without an MRI showing signs signs concerning for MS, as well as age-and sex-matched NON-FDRs who will have blood drawn and fill out the questionnaire. With this preliminary cross-sectional study, the investigators hope to begin to identify a risk stratification model for those at highest risk of developing MS, ie FDRs, with a long-term goal of developing a longitudinal study to increase sensitivity and specificity of the risk model.

Conditions

  • Multiple Sclerosis
  • Magnetic Resonance Imaging
  • Biomarkers
  • Clinically Isolated Syndrome
  • Radiologically Isolated Syndrome

Interventions

DIAGNOSTIC_TEST

Brain MRI

Perform brain MRI; draw blood; fill out bioscreen questionnaire; perform SDMT

Sponsors & Collaborators

  • Colorado School of Public Health

    collaborator OTHER
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • John R Corboy, MD · University of Colorado, Denver

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-26
Primary Completion
2024-05-31
Completion
2024-05-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03586986 on ClinicalTrials.gov