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Identifying and Characterizing Preclinical MS

NCT ID: NCT05787795

Last Updated: 2025-11-14

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

2022-06-21

Study Completion Date

2033-06-30

Brief Summary

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The purpose of this research study is to try and identify risk factors and biologic changes that suggest that someone may go on to develop multiple sclerosis before a person has shown any symptoms of the disease.

Detailed Description

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The purpose of this study is to try and learn how to identify multiple sclerosis (MS) before it causes any neurologic symptoms. By the time MS causes symptoms, the disease has often been causing damage under the surface for years. Because early treatment of MS helps prevent long term disability from the disease, the investigators are hypothesizing that if MS could be detected (and treated) before symptoms start, the disease might be preventable.

The investigators believe that people who go on to develop MS have changes in their immune systems long before they have symptoms. Some of these changes might be in "hidden" parts of the body, like lymph nodes or fat tissue. The investigators want to study people who have risk factors for MS to try and learn to detect very early signs of disease.

Study procedures will include:

All study participants will undergo a blood draw and an oral swab; they will also complete baseline questionnaires All study participants will be contacted approximately once per year and asked to complete some additional questionnaires All study participants may be asked to donate repeat blood/oral swab specimens or stool specimens over time on an ad hoc basis Study participants who agree will undergo additional optional procedures to study the immune system in different parts of the body.

The optional procedures include:

Lumbar punctures (to obtain spinal fluid) Tonsil biopsy Fat biopsy (to obtain fat cells) Lymph node biopsy (to obtain lymph node tissues with immune cells) Traditional brain MRI Low-field (portable) brain MRI

One in-person visit is required. There will also be annual phone/email contact, which may take up to 30 minutes The required in-person visit will take approximately 1 hour total. Anyone who agrees to donate follow up biospecimens, undergo a procedure, or undergo an MRI will have additional in-person visits Optional visits for donating biospecimens, having a procedure or getting an MRI may take longer (up to 3 hours), depending on what is happening during the visit.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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biological samples

blood draw, oral swab, optional stool samples, spinal fluid sample, fat biopsy, tonsil biopsy, lymph node tissue sample, MRI

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Age 18+
* Having one or more risk factors for multiple sclerosis, including one or more of the below:

* Individuals known to have a radiologically isolated syndrome
* Individuals with a family history of multiple sclerosis (first degree family member)
* Individuals with personal risk factors, which are known to include smoking, obesity, Epstein Barr virus infections, Vitamin D deficiency, genetic risk score

Exclusion Criteria

* Currently pregnant
* Diagnosis of multiple sclerosis or any ongoing, systemic autoimmune disease
* Ongoing treatment with immunosuppressive medications
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roche-Genentech

INDUSTRY

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erin Longbrake, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

North Haven, Connecticut, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Erin Longbrake, MD

Role: CONTACT

Phone: 860-287-6100

Email: [email protected]

Facility Contacts

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Cynthia Marques

Role: primary

Other Identifiers

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2000032952

Identifier Type: -

Identifier Source: org_study_id