Multiple SclerosisEBV-RISNCT05815108
Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome
An observational study of Multiple Sclerosis and Radiologically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
The clinical course of RRMS patients is variable. Among RIS-Consortium international cohorts, one third of RIS patients progressed to MS at 5 years and 52.2% at 10 years. Biomarkers predictive of MS conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Multiple Sclerosis, Radiologically Isolated Syndrome, Epstein-Barr Virus
- How many people
- 156 participants
- Where
- 1 siteFrance
- Study dates
- 15 Mar 2023to 17 Mar 2023
- 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 15 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Patients with RIS confirmed by the RIS expert center of the Nice CHU, included in the international cohort of the RIS Consortium for which retrospective serological data are available.
Who may be able to join
- Patients with RIS confirmed by the RIS expert center of the Nice CHU; EBNA status at RIS diagnosis available
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence and Prognostic Value of Epstein Barr Virus (EBV) Infection in Patients With Radiologically Isolated Syndrome (RIS)
The clinical course of RRMS patients is variable. Among RIS-Consortium international cohorts, one third of RIS patients progressed to MS at 5 years and 52.2% at 10 years. Biomarkers predictive of MS conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. EBV seems to be an interesting candidate regarding its involvement MS pathophysiology. It can be easily assess in blood sample in contrast to others prognostic biomarkers validated in RIS : oligoclonal bands and NfL levels in cerebrospinal fluid and serum. In RIS, treatment targeting EBV could significantly modify the course of the disease. The investigators aim to make the fisrt description of the EBV epidemiology (immunoglobulin (Ig)M and IgG anti-viral capsid antigen (VCA), IgG anti Epstein-Barr nuclear antigen (EBNA)) among RIS patients and to investigate a correlation between the different antibodies' titers (IgM VCA, IgG VCA, IgG EBNA) and the course of the disease (clinical conversion or evidence of disease activity (EDA)).
- Being tested
- NO INTERVENTION
- Medical subject headings
- Multiple Sclerosis, Epstein-Barr Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTIONOther
NO INTERVENTION
| Study group | Role | What they receive |
|---|---|---|
| RIS Patient | RIS patients validated by the RIS expert group Receives: Other: NO INTERVENTION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparaison of IgG EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
IgG EBNA (negative/positive)
Measured: Retrospectively at baseline (RIS diagnosis)
Secondary outcomes (6)
Comparaison of IgM VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
quantity of IgM VCA EBNA (U/ml)
Measured: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Comparaison of IgG VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
quantity of IgM VCA EBNA (U/ml)
Measured: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Prevalence of EBV seropositivity in RIS patients according to their MRI activity
EBV seropositivity (negative/positive) according clinical event and Dissemination in time and in space
Measured: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Prevalence of EBV seropositivity in RIS patients according to their clinical and/or MRI activity (EDA)
EBV seropositivity (negative/positive) according clinical event and Dissemination in time and in space
Measured: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Assessment correlation between antibodies titers and clinical conversion
quantity of IgG VCA EBNA (U/ml) and IgM VCA EBNA (U/ml) according Dissemination in time and in space
Measured: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Assessment correlation between antibodies titers and clinical and/or MRI activity (EDA)
quantity of IgG VCA EBNA (U/ml) and quantity of IgM VCA EBNA (U/ml) according clinical event and Dissemination in time and in space
Measured: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start15 Mar 2023
- Primary completion17 Mar 2023
- Study completion17 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815108
- Sponsor's protocol ID
- 23Neuro01
- Acronym
- EBV-RIS
- Status last verified
- May 2025
- First submitted
- 8 Mar 2023
- Last updated
- 8 May 2025
- 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 8 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Prognostic Value of Epstein Barr Virus (EBV) Infection in Patients With Radiologically Isolated Syndrome (RIS)
- ClinicalTrials.gov ID
- NCT05815108
- Acronym / sponsor ID
- EBV-RIS / 23Neuro01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 17 Mar 2023 (actual)
- Study completion
- 17 Mar 2023 (actual)
- First posted
- 18 Apr 2023 (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 clinical course of RRMS patients is variable. Among RIS-Consortium international cohorts, one third of RIS patients progressed to MS at 5 years and 52.2% at 10 years. Biomarkers predictive of MS conversion are key elements to organize personalized medical care, for both follow-up and treatment strategies. EBV seems to be an interesting candidate regarding its involvement MS pathophysiology. It can be easily assess in blood sample in contrast to others prognostic biomarkers validated in RIS : oligoclonal bands and NfL levels in cerebrospinal fluid and serum. In RIS, treatment targeting EBV could significantly modify the course of the disease. The investigators aim to make the fisrt description of the EBV epidemiology (immunoglobulin (Ig)M and IgG anti-viral capsid antigen (VCA), IgG anti Epstein-Barr nuclear antigen (EBNA)) among RIS patients and to investigate a correlation between the different antibodies' titers (IgM VCA, IgG VCA, IgG EBNA) and the course of the disease (clinical conversion or evidence of disease activity (EDA)).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RIS Patient | – | Other: NO INTERVENTIONRIS patients validated by the RIS expert group |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with RIS confirmed by the RIS expert center of the Nice CHU, included in the international cohort of the RIS Consortium for which retrospective serological data are available.
Key inclusion criteria (1 listed)
- Patients with RIS confirmed by the RIS expert center of the Nice CHU; EBNA status at RIS diagnosis available
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| NO INTERVENTIONNO INTERVENTION | Other | RIS Patient |
Primary outcome
Comparaison of IgG EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
Time frame: Retrospectively at baseline (RIS diagnosis)
IgG EBNA (negative/positive)
6 secondary outcomes
Comparaison of IgM VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
Time frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Comparaison of IgG VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay
Time frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Prevalence of EBV seropositivity in RIS patients according to their MRI activity
Time frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Prevalence of EBV seropositivity in RIS patients according to their clinical and/or MRI activity (EDA)
Time frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Assessment correlation between antibodies titers and clinical conversion
Time frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
Assessment correlation between antibodies titers and clinical and/or MRI activity (EDA)
Time frame: Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.
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 8 May 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multiple Sclerosis and Radiologically Isolated Syndrome, run by Centre Hospitalier Universitaire de Nice 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 1 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 8 May 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?
Comparaison of IgG EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay (time frame: Retrospectively at baseline (RIS diagnosis)). 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 8 May 2025.