MS-ResearchBiomarkerS

NCT05204459 | Recruiting

• 1 other identifier: STUDY00001690
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Identifying risk factors for disability progression

  To investigate whether combining information from peripheral blood biomarkers, retinal structural, visual function, as well as historical and ongoing longitudinal MRIs (brain, cervical, and/or thoracic spinal cord) can predict quantitative disability progression risk

  10 years

Secondary Outcomes (3)

• Effect of disease modifying therapy

  10 years

• Identify factors associated with visual disability and optic neuropathy in multiple sclerosis and related disorders

  10 years

• Identify serum, genetic, and stem cell-derived biomarkers influencing disability risks

  10 years

Study Arms (5)

RRMS, SPMS, PPMS, CIS or RIS

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

NMOSD

Neuromyelitis optica spectrum disorders

MOGAD

Myelin oligodendrocyte glycoprotein antibody disorders

Neurological disorder other than MSRD

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

Healthy controls

Healthy controls with no known neurological conditions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants with the following conditions or healthy volunteers are eligible to participate in the study: 1. Multiple sclerosis (MS), clinically isolated syndrome (CIS), or radiologically isolated syndrome (RIS) 2. Neuromyelitis optica spectrum disorders (NMOSD) 3. Myelin oligodendrocyte glycoprotein (MOG) antibody associated disorders (MOGAD) 4. Neurological disorder other than MS and related disorders 5. Healthy volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Related Links

• Cedars-Sinai Clinical Research Website

Biospecimen

Retention: SAMPLES WITH DNA

* 2 red top tubes for serum collection (10 mL of blood each) * 2 purple top tube for DNA, Plasma, and Buffy Coat (10 mL of blood each) * 1 green top tube(10 mL of blood each) * 1 BD Vacutainer® CPT™ Tube with Sodium Citrate (part of an additional stem cell/genetic study blood draw; 8-10 mL of blood each)

MeSH Terms

Conditions

Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis, Chronic Progressive; Neuromyelitis Optica; Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease; Autoimmune Diseases of the Nervous System; Nervous System Diseases

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Myelitis, Transverse; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Eye Diseases

Study Officials

• Omar Al-Louzi, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

• Marwa Kaisey, MD

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

• Brooke Guerrero, MD

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

• Laura Locke, CRNP

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

• Pascal Sati, PhD

  Cedars-Sinai Medical Center

  STUDY DIRECTOR

• Nancy Sicotte, MD

  Cedars-Sinai Medical Center

  STUDY CHAIR

Central Study Contacts

Omar Al-Louzi, MD

CONTACT

(310) 423-4008; omar.allouzi@cshs.org

Group Neurology Research

CONTACT

(310)-423-6472; GroupNeurologyMSProgramResearch@cshs.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician; Director, Visual Outcomes Lab

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: January 24, 2022
• Study Start: November 11, 2021
• Primary Completion (Estimated): November 11, 2041
• Study Completion (Estimated): November 11, 2041
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

US (1)