Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation

NCT ID: NCT06957145

Last Updated: 2025-09-03

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

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-30

Study Completion Date

2026-12-30

Brief Summary

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The aim of this study is to investigate whether VISTA, a newly identified negative immune regulatory protein, differs in monocytes and T cells of patients diagnosed with Multiple Sclerosis (MS) and Clinically Isolated Syndrome (CIS) compared to the same cell types in healthy controls. Additionally, the potential clinical correlation of VISTA expression in the follow-up of MS and CIS patients will be examined. By elucidating the role of VISTA in the pathophysiology of MS, this study will contribute to the literature by exploring its potential as a biomarker and its relevance in the development of novel therapeutic strategies.

Specifically, this study will compare VISTA protein secretion in MS patients at the time of their first attack with that of healthy controls. Furthermore, changes in VISTA protein secretion will be assessed in blood samples collected at 6- and 12-month follow-ups, and the correlations of these changes with clinical and laboratory findings will be investigated.

Finally, this study aims to determine whether CD4+ and CD8+ T cells, monocytes, and T regulatory (Treg) subgroups in the first attack blood samples of MS patients exhibit similar functional properties in terms of VISTA protein secretion as their counterparts in healthy controls. To achieve this, monocytes and T cell subtypes will be stimulated, and their pro- and anti-inflammatory cytokine responses will be analyzed.

Detailed Description

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Conditions

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Multiple Sclerosis, MS

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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People with MS

30 People with MS

No interventions assigned to this group

Health Control

30 Health Control

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients aged 18 years or older diagnosed with MS or CIS according to the 2017 McDonald criteria.
* No diagnosis of any autoimmune disease or malignancy.
* No new diagnosis of autoimmune disease or malignancy during the 1-year follow-up period.
* No use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroid treatments within one month prior to blood sampling.
* No vaccination within one month prior to blood sampling.
* Not in the menstrual cycle at the time of blood sampling.

Exclusion Criteria

* Age below 18 years.
* Presence of a previous or newly diagnosed autoimmune disease or malignancy at the time of blood sampling.
* Use of antibiotics, nonsteroidal anti-inflammatory drugs (NSAIDs), or steroid treatments within one month prior to blood sampling.
* Vaccination within one month prior to blood sampling
* Being in the menstrual cycle at the time of blood sampling
* Patients without a definitive MS diagnosis according to the 2017 McDonald criteria will not be included in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Koç University

OTHER

Sponsor Role lead

Responsible Party

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Rabia Gökcen Gozubatik Celik

Assoc. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rabia G Gozubatik Celik, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Koç University

Locations

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Koc University

Istanbul, Istanbul, Turkey (Türkiye)

Site Status RECRUITING

Bakirkoy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatric, Neurologic and Neurosurgical Diseases, University of Health Sciences, Istanbul, Turkey

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Facility Contacts

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Rabia Gokcen Gozubatik Celik

Role: primary

05549370087

Rabia Gokcen Gozubatik Celik

Role: primary

05549370087

Other Identifiers

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Vista Protein Expression in MS

Identifier Type: -

Identifier Source: org_study_id

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