RECRUITING

Risk Factors in Early Multiple Sclerosis

Conditions

Multiple Sclerosis Magnetic Resonance Imaging Biomarkers Clinically Isolated Syndrome Radiologically Isolated Syndrome First degree relative

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Risk Factors in Early Multiple Sclerosis

Quick Facts

Study Start:2018-07-26

Study Completion:2024-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03586986

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 30 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Not specified

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

John R Corboy, MD

CONTACT

303-724-2187

john.corboy@ucdenver.edu

Sydney Lipton, BA

CONTACT

sydney.lipton@cuanschutz.edu

Principal Investigator

John R Corboy, MD

PRINCIPAL_INVESTIGATOR

University of Colorado - Anschutz Medical Campus

Study Locations (Sites)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045

United States

Collaborators and Investigators

Sponsor: University of Colorado, Denver

John R Corboy, MD, PRINCIPAL_INVESTIGATOR, University of Colorado - Anschutz Medical Campus

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-07-26

Study Completion Date2024-05

Study Record Updates

Study Start Date2018-07-26

Study Completion Date2024-05

Terms related to this study

Keywords Provided by Researchers

First degree relative

Additional Relevant MeSH Terms

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