MS-ResearchBiomarkerS

NCT ID: NCT05204459

Last Updated: 2024-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-11

Study Completion Date

2041-11-11

Brief Summary

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This study is being conducted to investigate risk factors for disability progression in Multiple Sclerosis and related disorders (MSRD). The primary goal is to assess whether combining information from visual assessment, blood markers, as well as historical and ongoing longitudinal MRIs of the brain, orbit (the part of the skull where eyes are located), and/or spinal cord can predict changes in quantitative disability measures related to MSRD and neurological disease.

Detailed Description

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Screening:

Prospective participants will be screened at Cedars-Sinai Medical Center (CSMC) through a comprehensive review of their medical and MRI records done as part of standard of care to determine if they are eligible to participate in this study. If they never had an MRI at CSMC, they will be asked to provide records of an MRI done at another site. If the study team determines that they are eligible to continue participating, then they will move on to the main research study.

Main Research Study:

The following items will be collected as part of the main research study:

* Demographic data and medical history, including medications, family, and social history
* Complete a series of quantitative disability assessments,
* Collection of historic MRI data obtained as part of standard of care

Optional Sub-study:

Participants are not required to take part in the optional sub-study and can choose which sub-study procedures they would want to undergo. Participants can say no to the sub-study, and still remain in the main study. The optional sub-study involves undergoing one or more of the procedures below:

* Research blood draw
* Additional blood sample for a genetic and/or stem cell sub-study
* Visual assessment
* Research MRI

How long will participants be in the study? There is no prespecified end date for this study. Participants may remain in the main study as long as they are (1) willing to participate, (2) remain eligible for the study procedures, and (3) the study remains open.

Compensation for Participating Participants will be provided a voucher to cover parking expenses at Cedars-Sinai Medical Center during their participation in this research study if they undergo the optional sub-study procedures.

Conditions

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Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progressive Clinically Isolated Syndrome Radiologically Isolated Syndrome Neuromyelitis Optica Spectrum Disorders Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease Neurologic Autoimmune Disease Neurologic Disorder Healthy Aging

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RRMS, SPMS, PPMS, CIS or RIS

Multiple Sclerosis (relapsing-remitting, primary or secondary progressive forms), clinically isolated syndrome, or radiologically isolated syndrome

No interventions assigned to this group

NMOSD

Neuromyelitis optica spectrum disorders

No interventions assigned to this group

MOGAD

Myelin oligodendrocyte glycoprotein antibody disorders

No interventions assigned to this group

Neurological disorder other than MSRD

Neurological disorders due to neurodegenerative, vascular, or headache conditions that are not related to multiple sclerosis or related disorders.

No interventions assigned to this group

Healthy controls

Healthy controls with no known neurological conditions

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subjects who meet any one of the following diagnostic criteria:

* Diagnosis of MS, CIS,or RIS based on the 2017 revised McDonald criteria.
* Diagnosis of NMOSD based on the 2015 revised NMOSD consensus diagnostic criteria.
* Diagnosis of myelin oligodendrocyte glycoprotein (MOG)-related encephalomyelitis, optic neuritis, or other associated disease.
* Diagnosis of neurological disorders other than MSRD.
* Healthy volunteer.
* Age ≥18.
* Able to give informed consent.

Exclusion Criteria

* Patients will be excluded from the MRI portions of the study if they have a contraindication to MRI(metallic implantsor foreign bodies, claustrophobia, MRI-incompatible pacemakers, MRI- incompatible prosthetic heart valves).
* Patients will be excluded from the MRI portions of the study if they are pregnant, but their demographic, clinical information,and disability measures may still be captured under the study.
* Patients will be excluded from the visual assessment portions of the study if they have had any recent ocular surgery (within the past two months), refractive errors of greater than or equal to ±6 diopters or other eye diseases that may affect or confound OCT/OCTA measurements (ex., age-related macular degeneration, advanced geographic atrophy, diabetic retinopathy, glaucoma).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cedars-Sinai Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Omar Al-Louzi

Staff Physician; Director, Visual Outcomes Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Omar Al-Louzi, MD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Marwa Kaisey, MD

Role: STUDY_DIRECTOR

Cedars-Sinai Medical Center

Brooke Guerrero, MD

Role: STUDY_DIRECTOR

Cedars-Sinai Medical Center

Laura Locke, CRNP

Role: STUDY_DIRECTOR

Cedars-Sinai Medical Center

Pascal Sati, PhD

Role: STUDY_DIRECTOR

Cedars-Sinai Medical Center

Nancy Sicotte, MD

Role: STUDY_CHAIR

Cedars-Sinai Medical Center

Locations

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Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Omar Al-Louzi, MD

Role: CONTACT

(310) 423-4008

Group Neurology Research

Role: CONTACT

(310)-423-6472

Facility Contacts

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Omar Al-Louzi, MD

Role: primary

310-423-4008

Group Neurology Research

Role: backup

(310)-423-6472

Related Links

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Other Identifiers

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STUDY00001690

Identifier Type: -

Identifier Source: org_study_id

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