Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-26 @ 10:58 AM
Study NCT ID:
NCT05815108
Status:
COMPLETED
Last Update Posted:
2025-05-08
First Post:
2023-03-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020031', 'term': 'Epstein-Barr Virus Infections'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 156}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-05', 'studyFirstSubmitDate': '2023-03-08', 'studyFirstSubmitQcDate': '2023-04-03', 'lastUpdatePostDateStruct': {'date': '2025-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparaison of IgG EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay', 'timeFrame': 'Retrospectively at baseline (RIS diagnosis)', 'description': 'IgG EBNA (negative/positive)'}], 'secondaryOutcomes': [{'measure': 'Comparaison of IgM VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay', 'timeFrame': 'Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.', 'description': 'quantity of IgM VCA EBNA (U/ml)'}, {'measure': 'Comparaison of IgG VCA EBNA status at RIS diagnostic in patients who remain RIS and those who develop MS according to their conversion delay', 'timeFrame': 'Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.', 'description': 'quantity of IgM VCA EBNA (U/ml)'}, {'measure': 'Prevalence of EBV seropositivity in RIS patients according to their MRI activity', 'timeFrame': 'Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.', 'description': 'EBV seropositivity (negative/positive) according clinical event and Dissemination in time and in space'}, {'measure': 'Prevalence of EBV seropositivity in RIS patients according to their clinical and/or MRI activity (EDA)', 'timeFrame': 'Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.', 'description': 'EBV seropositivity (negative/positive) according clinical event and Dissemination in time and in space'}, {'measure': 'Assessment correlation between antibodies titers and clinical conversion', 'timeFrame': 'Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.', 'description': 'quantity of IgG VCA EBNA (U/ml) and IgM VCA EBNA (U/ml) according Dissemination in time and in space'}, {'measure': 'Assessment correlation between antibodies titers and clinical and/or MRI activity (EDA)', 'timeFrame': 'Retrospectively at baseline (RIS diagnosis) and through study completion, an average of 5 years.', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Radiologically Isolated Syndrome', 'Epstein-Barr Virus']}, 'descriptionModule': {'briefSummary': "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))."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients with RIS confirmed by the RIS expert center of the Nice CHU; EBNA status at RIS diagnosis available\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT05815108', 'acronym': 'EBV-RIS', 'briefTitle': 'Epstein Barr Virus Infection in Patients With Radiologically Isolated Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Prevalence and Prognostic Value of Epstein Barr Virus (EBV) Infection in Patients With Radiologically Isolated Syndrome (RIS)', 'orgStudyIdInfo': {'id': '23Neuro01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RIS Patient', 'description': 'RIS patients validated by the RIS expert group', 'interventionNames': ['Other: NO INTERVENTION']}], 'interventions': [{'name': 'NO INTERVENTION', 'type': 'OTHER', 'description': 'NO INTERVENTION', 'armGroupLabels': ['RIS Patient']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'country': 'France', 'facility': 'Nice University Hospital', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}