Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT03586986

Conditions

Multiple Sclerosis

Magnetic Resonance Imaging

Biomarkers

Clinically Isolated Syndrome

Radiologically Isolated Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Interventions

Brain MRI

Study Details

Brief 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

Study ID

NCT03586986

Start date

Jul 26, 2018

Status verified date

Feb, 2023

Completion date

May, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 30

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • FDR Inclusion Criteria

1. Male and female
2. All races and ethnicities
3. Ages 18-30
4. Must have a parent, sibling or child with MS fulfilling McDonald 2017 criteria
5. No symptoms suggestive of MS on formal screen
6. Ability to undergo a non-contrast MRI and venipuncture, and perform an environmental screen, mood screen and cognitive test
  • Non-FDR Inclusion Criteria

1. Male and female
2. All races and ethnicities
3. Ages 18-30
4. Must NOT have a FDR (parent, sibling, child) or second degree relative (grandparent, aunt or uncle) with MS fulfilling McDonald 2017 criteria
5. No symptoms suggestive of MS on formal screen
6. Ability to undergo venipuncture and perform an environmental screen.

Exclusion Criteria:

  • FDR Exclusion Criteria

1. Symptoms suggestive of MS on formal screen
2. Prior diagnosis of autoimmune disease that may be associated with CNS dysfunction and MRI lesions, e.g. Sjogren's
  • Non-FDR Exclusion Criteria

1. Symptoms suggestive of MS on formal screen
2. Prior diagnosis of autoimmune disease that may be associated with CNS dysfunction and MRI lesions, e.g. Sjogren's

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

FDR with abnormal brain MRI

First degree relatives fulfilling lesions disseminated in space on MRI

FDR with normal brain MRI

First degree relatives not fulfilling lesions disseminated in space on MRI

Non-FDR

Age and sex-matched controls to FDRs noted above

Interventions

Brain MRI

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

Primary outcome measure

  • Discovery of Lesions disseminated in space on brain MRI [ Time Frame: At the subject's Initial Visit ]

Central Contacts and Locations

Central contacts

John R Corboy, MD

303-724-2187john.corboy@ucdenver.edu

Sydney Lipton, BA

sydney.lipton@cuanschutz.edu

Locations

University of Colorado Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

John Corboy, MD

303-724-2187john.corboy@ucdenver.edu

Principal Investigator:

John Corboy, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

Feb 6, 2023

Last verified

Feb, 2023

Keywords

  • First degree relative

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2023-02-06.