Vista Protein Expression of Monocyte and T Cell Subsets i... | NCT06957145

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

NCT06957145

Sponsor

Koç University

Status

Recruiting

Last Update Posted

Sep 3, 2025Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Multiple Sclerosis, MS

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 30, 2025Actual

Primary Completion Date

Jan 30, 2026Estimated

Completion Date

Dec 30, 2026Estimated

First Submitted Date

Mar 17, 2025

First Submission Date that Met QC Criteria

Apr 25, 2025

First Posted Date

May 4, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 30, 2025

Last Update Posted Date

Sep 3, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Label	Type	Description	Intervention Names
People with MS		30 People with MS
Health Control		30 Health Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VISTA Protein Secretion	Comparison of VISTA protein secretion levels in blood samples of MS patients at the time of their first attack with those of healthy controls.	Baseline, Week 0

Secondary Outcomes

Measure	Description	Time Frame
Functional Comparison of Immune Cell Subsets via Cytokine Profiling and VISTA Expression Analysis	VISTA protein expression levels in CD4+ and CD8+ T cells, monocytes, and regulatory T (Treg) cell subgroups from first attack blood samples of pwMS and healthy controls, measured by flow cytometry. VISTA protein secretion levels in the same cell subgroups, measured by multiplex cytokine assays. Cytokine responses (pro- and anti-inflammatory) in stimulated monocytes and T cell subsets, measured by flow cytometry and multiplex cytokine assays.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Multiple Sclerosis

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Rabia G Gozubatik Celik, Assoc. Prof.	Koç University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Koc University	Recruiting	Istanbul	Istanbul		Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided