Radiologically Isolated SyndromeRIS - EBVDNCT07256431
Environmental Risk Factors in Multiple Sclerosis Development: Epidemiological Study of EBV Infection and Vitamin D Deficiency in RIS Patients
An observational study of Radiologically Isolated Syndrome and Epstein-Barr Virus Infections, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
This is an ancillary study using samples collected in the ProBioRIS cohort (NCT06395662). The aim of the project is to highlight new biomarker candidates to assess the risk of conversion to clinically definite multiple sclerosis (CDMS) and disease activity (Evidence of Disease Activity) by taking into account… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Radiologically Isolated Syndrome, Epstein-Barr Virus Infections
- What is being tested?
- Antibiody titration
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2023to 30 Jul 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with RIS taken from ProBioRIS cohort (NCT06395662) plus healthy controls taken from the VDSS study (NCT05654818).
Who may be able to join
- RIS patients from the ProBioRIS study with sufficient serum residuals for vitamin D testing and complete EBV serology.
- Healthy subjects who participated in the VDSS trial and who provided consent for the use, for basic research purposes, of human biological samples collected during the trial.
Who cannot join
- Insufficient sample
Trial locations and contacts
1 site in 1 country.
About this study
This is an ancillary study using samples collected in the ProBioRIS cohort (NCT06395662). The aim of the project is to highlight new biomarker candidates to assess the risk of conversion to clinically definite multiple sclerosis (CDMS) and disease activity (Evidence of Disease Activity) by taking into account demographic, clinical and MRI parameters. A cohort of healthy subjects will be integrated into the study to serve as a control population. We will study a panel of serum immunoglobulins targeting different Epstein Barr virus antigens to identify latency or reactivation phases. Identifying and prioritizing risk factors for clinical conversion to MS in radiologically isolated syndrome patients is of major importance for the implementation of personalized monitoring and treatment strategies, especially following the recent highlighting of the benefit of background treatments in patients at high risk of CDMS.
- Being tested
- Antibiody titration
- Medical subject headings
- Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiody titrationOther
Search for EBV seropositivity using SIMAO assay
| Study group | Role | What they receive |
|---|---|---|
| Patients with radiologically isolated syndrome | Not described Receives: Other: Antibiody titration | |
| Healthy controls | Not described Receives: Other: Antibiody titration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of EBV seropositivity in RIS patients
Measured by single-molecule array (SIMOA)
Measured: Baseline
Serum vitamin D levels in patients with RIS
Measured with mass spectrometry
Measured: Baseline
Disease activity in patients with RIS
Evidence of disease aftivity versus no evidence of disease activity
Measured: Baseline
Secondary outcomes (1)
Prevalence of EBV seropositivity in healthy controls
Measured by single-molecule array (SIMOA)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start1 Aug 2023
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiologically Isolated SyndromeStudies 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
- Retrospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Thouvenot, Principal investigator, CHU de Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256431
- Sponsor's protocol ID
- LOCAL/2025/PROBIORIS/EBVD
- Acronym
- RIS - EBVD
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Risk Factors in Multiple Sclerosis Development: Epidemiological Study of EBV Infection and Vitamin D Deficiency in RIS Patients
- ClinicalTrials.gov ID
- NCT07256431
- Acronym / sponsor ID
- RIS - EBVD / LOCAL/2025/PROBIORIS/EBVD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 1 Dec 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.
This is an ancillary study using samples collected in the ProBioRIS cohort (NCT06395662). The aim of the project is to highlight new biomarker candidates to assess the risk of conversion to clinically definite multiple sclerosis (CDMS) and disease activity (Evidence of Disease Activity) by taking into account demographic, clinical and MRI parameters. A cohort of healthy subjects will be integrated into the study to serve as a control population. We will study a panel of serum immunoglobulins targeting different Epstein Barr virus antigens to identify latency or reactivation phases. Identifying and prioritizing risk factors for clinical conversion to MS in radiologically isolated syndrome patients is of major importance for the implementation of personalized monitoring and treatment strategies, especially following the recent highlighting of the benefit of background treatments in patients at high risk of CDMS.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with radiologically isolated syndrome | – | Other: Antibiody titration |
| Healthy controls | – | Other: Antibiody titration |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with RIS taken from ProBioRIS cohort (NCT06395662) plus healthy controls taken from the VDSS study (NCT05654818).
Key inclusion criteria (2 listed)
- RIS patients from the ProBioRIS study with sufficient serum residuals for vitamin D testing and complete EBV serology.
- Healthy subjects who participated in the VDSS trial and who provided consent for the use, for basic research purposes, of human biological samples collected during the trial.
Key exclusion criteria (1 listed)
- Insufficient sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiody titrationSearch for EBV seropositivity using SIMAO assay | Other | Healthy controls, Patients with radiologically isolated syndrome |
Primary outcome
Prevalence of EBV seropositivity in RIS patients
Time frame: Baseline
Measured by single-molecule array (SIMOA)
Serum vitamin D levels in patients with RIS
Time frame: Baseline
Measured with mass spectrometry
Disease activity in patients with RIS
Time frame: Baseline
Evidence of disease aftivity versus no evidence of disease activity
1 secondary outcome
Prevalence of EBV seropositivity in healthy controls
Time frame: Baseline
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 1 Dec 2025.
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Clinical Impact Through AI-assisted MS Care - A Retrospective Multi-center Observational Study.
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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.
Eric Thouvenot principal investigator
CHU de Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Radiologically Isolated Syndrome and Epstein-Barr Virus Infections, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 2 inclusion and 1 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 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Prevalence of EBV seropositivity in RIS patients (time frame: Baseline). The study lists 3 primary outcomes in all. 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 1 Dec 2025; AzTrials last refreshed its copy on 29 Oct 2026.