Environmental Risk Factors in Multiple Sclerosis Development: Epidemiological Study of EBV Infection and Vitamin D Deficiency in RIS Patients

NCT ID: NCT07256431

Last Updated: 2025-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-08-01

Study Completion Date

2024-07-30

Brief Summary

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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.

Detailed Description

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Conditions

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Radiologically Isolated Syndrome Epstein-Barr Virus Infections

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with radiologically isolated syndrome

Antibiody titration

Intervention Type OTHER

Search for EBV seropositivity using SIMAO assay

Healthy controls

Antibiody titration

Intervention Type OTHER

Search for EBV seropositivity using SIMAO assay

Interventions

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Antibiody titration

Search for EBV seropositivity using SIMAO assay

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

• Insufficient sample
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Thouvenot

Role: PRINCIPAL_INVESTIGATOR

CHU de Nimes

Locations

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CHU de Nîmes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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LOCAL/2025/PROBIORIS/EBVD

Identifier Type: -

Identifier Source: org_study_id

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