Multiple Sclerosis, MSNCT06957145
Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation
An observational study of Multiple Sclerosis, MS, run by Koç University at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, MS
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 30 Jun 2025to 12 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Multiple Sclerosis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Koc University
Istanbul, Istanbul
Bakirkoy Prof. Dr. Mazhar Osman Training and Research Hospital for Psychiatric, Neurologic and Neurosurgical Diseases, University of Health Sciences, Istanbul, Turkey
Istanbul
About this study
Official title: Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation: A 1-Year Follow-up Study
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.
- Conditions
- Multiple Sclerosis, MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| People with MS | 30 People with MS | |
| Health Control | 30 Health Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 0
Secondary outcomes (2)
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.
Measured: Baseline, Week 0
Clinical and Radiological Correlation
Demographic data, routine neurological examination findings, EDSS scores, cerebrospinal fluid (CSF) results, and MRI findings collected during the 1-year follow-up. Visual Evoked Potential (VEP) measurements during the same period. VISTA protein secretion levels and temporal changes measured by multiplex cytokine assays
Measured: Baseline, Month 6, Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start30 Jun 2025
- Primary completion30 Jan 2026
- Study completion12 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, MSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rabia Gökcen Gozubatik Celik, Koç University
- Investigators
- Rabia G Gozubatik Celik, Assoc. Prof., Principal investigator, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06957145
- Sponsor's protocol ID
- Vista Protein Expression in MS
- Status last verified
- Mar 2025
- First submitted
- 17 Mar 2025
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation: A 1-Year Follow-up Study
- ClinicalTrials.gov ID
- NCT06957145
- Acronym / sponsor ID
- Vista Protein Expression in MS
- Conditions
- Multiple Sclerosis, MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 30 Jun 2025 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with MS | – | –30 People with MS |
| Health Control | – | –30 Health Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Multiple Sclerosis
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VISTA Protein Secretion
Time frame: Baseline, Week 0
Comparison of VISTA protein secretion levels in blood samples of MS patients at the time of their first attack with those of healthy controls.
2 secondary outcomes
Functional Comparison of Immune Cell Subsets via Cytokine Profiling and VISTA Expression Analysis
Time frame: Baseline, Week 0
Clinical and Radiological Correlation
Time frame: Baseline, Month 6, Month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia G Gozubatik Celik, Assoc. Prof. principal investigator
Koç University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, MS, run by Koç University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VISTA Protein Secretion (time frame: Baseline, Week 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.