VISTA protein levels in monocytes and T cells in multiple sclerosis and CIS
Vista Protein Expression of Monocyte and T Cell Subsets in Multiple Sclerosis and Its Clinical Correlation: A 1-Year Follow-up Study
This study will test whether levels of the immune-regulating protein VISTA in monocytes and T cells differ between people with MS or CIS and healthy volunteers and whether those levels change over 6 and 12 months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Koç University Academic / other |
| Locations | 2 sites (Istanbul, Istanbul and 1 other locations) |
| Trial ID | NCT06957145 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort study measuring VISTA protein expression in monocytes and T cells from people with Multiple Sclerosis (MS) or Clinically Isolated Syndrome (CIS) and healthy controls. Blood samples will be collected at the first clinical attack (baseline) and again at 6- and 12-month follow-ups to measure VISTA secretion and to track changes over time. Clinical and laboratory data will be collected in parallel to explore correlations between VISTA levels and disease status or progression. Participants with recent antibiotics, NSAIDs, steroids, vaccinations, active menstrual bleeding, other autoimmune disease, or malignancy are excluded to reduce confounding of immune measurements.
Who should consider this trial
Good fit: Adults aged 18 or older with a confirmed diagnosis of MS or CIS by the 2017 McDonald criteria who have no other autoimmune disease or malignancy and who are not using antibiotics, NSAIDs, or steroids nor recently vaccinated or menstruating at sampling are ideal candidates.
Not a fit: People under 18, those without a definitive MS diagnosis by the 2017 McDonald criteria, or individuals with other autoimmune disease, malignancy, recent antibiotics/NSAIDs/steroid use, recent vaccination, or active menstrual bleeding at sampling are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could identify VISTA as a biomarker of disease activity or progression and inform development of new immune-targeted treatments for MS.
How similar studies have performed: VISTA is a relatively new immune checkpoint with limited clinical data in MS; preclinical and small translational studies suggest altered VISTA signaling in autoimmunity but clinical confirmation in MS remains limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Istanbul, Istanbul and 1 other locations
- Koc University — Istanbul, Istanbul, Turkey (Türkiye) (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) (Recruiting)
Study contacts
- Principal investigator: Rabia G Gozubatik Celik, Assoc. Prof. — Koç University
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.