Ignite Creation Date:
2025-12-24 @ 9:32 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT06455332
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2024-05-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2024-05-23', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Optic nerve involvement defined by occurrence of a recent clinical episode of ON', 'timeFrame': 'assessed at baseline'}, {'measure': 'Asymptomatic optic nerve involvement defined by MRI (detection of an optic nerve T2 hypersignal)', 'timeFrame': 'assessed at baseline'}, {'measure': 'Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a second MS clinical relapse', 'timeFrame': 'assessed every 6 months during 24 months'}, {'measure': 'Asymptomatic optic nerve involvement defined by OCT (GCIPL-IETD,3pm)', 'timeFrame': 'assessed at baseline'}, {'measure': 'Risk of a new clinical relapse will be assessed by the occurrence and time to onset of a CDMS', 'timeFrame': 'assessed every 6 months during 24 months'}], 'secondaryOutcomes': [{'measure': 'Asymptomatic optic nerve involvement will be defined by: - asymptomatic optic nerve T2 hypersignal detected on one or both optic nerve(s) - or by GCIPL-IETD,3pm measured by OCT - or by GCIPL-IETD≥3µm measured by OCT', 'timeFrame': 'assessed at baseline every 6 months during 24 months', 'description': 'Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination (M0, M6, M12, M18, M24)'}, {'measure': 'Time to the second clinical relapse occurrence will be assessed every 6 months during 24 months at each neurological examination', 'timeFrame': 'assessed at Month 0, Month 6, Month 12, Month 18, Month 24'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinically isolated syndrome', 'Multiple sclerosis', 'MRI', 'Optical coherence tomography', 'Optic nerve', 'Diagnostic criteria'], 'conditions': ['Clinically Isolated Syndrome', 'Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'Optic neuritis (ON) represents around 30% of clinical presentation of clinically isolated syndrome (CIS). Asymptomatic optic nerve involvement is very frequent in all stage of multiple sclerosis (MS) disease including the CIS. However, optic nerve is still not part of MS diagnosis criteria. The main objective of our regional and multicenter study is to evaluate the prognostic value of optic nerve involvement at the earliest clinical stage of MS (=CIS) for the diagnosis of clinically definite MS (2nd clinical relapse) and the delay until the 2nd relapse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients between 18 and 55 years old\n* Occurrence of CIS ≤ 6 months\n* With two T2 hypersignals on brain/spinal cord MRI suggestive of MS or with oligoclonal bands\n* Giving their written informed consent\n\nExclusion Criteria:\n\n* Pathological conditions that may skew the optic nerve MRI and/or retinal OCT (diabetes mellitus, glaucoma, retinopathy, ametropia \\>6 dioptria)\n* Past history of MS relapses\n* Extensive myelitis (\\>3 vertebral bodies)\n* Bilateral optic neuritis without T2 lesions suggestive of MS\n* Contra-indication to MRI, gadolinium injection\n* Pregnancy, breast-feeding\n* Patients unable to consent'}, 'identificationModule': {'nctId': 'NCT06455332', 'acronym': 'HdeFIMS', 'briefTitle': 'Predictive Value of the Optic Nerve Involvement in Clinically Isolated Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': "Evaluation of the Predictive Value of the Optic Nerve Involvement at the Stage of Clinically Isolated Syndrome, for the Diagnosis of Clinically Definite Multiple Sclerosis and the Delay of Second Relapses' Occurrence", 'orgStudyIdInfo': {'id': '2021_0474'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'All patients will part of the same follow-up study.', 'description': 'All patients will part of the same follow-up study. No treatment will be compared. Patients will be treated as recommended.', 'interventionNames': ['Other: Optic nerve MRI sequence']}], 'interventions': [{'name': 'Optic nerve MRI sequence', 'type': 'OTHER', 'description': 'Systematic optic nerve MRI sequence during the CIS diagnosis work-up. This sequence is not done systematically and not recommended for now (except in case of acute ON). The interventional nature of the study remains minimal', 'armGroupLabels': ['All patients will part of the same follow-up study.']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59037', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Olivier Outteryck', 'role': 'CONTACT'}], 'facility': 'Hôpital Roger Salengro', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Juliette Bochu', 'role': 'CONTACT', 'email': 'juliette.bochu@chu-lille.fr', 'phone': '0320444145'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'collaborators': [{'name': 'Région Nord-Pas de Calais, France', 'class': 'OTHER'}, {'name': 'Amiens University Hospital', 'class': 'OTHER'}, {'name': 'Boulogne sur Mer Hospital Center', 'class': 'OTHER'}, {'name': 'Centre Hospitalier VALENCIENNES', 'class': 'OTHER'}, {'name': 'Centre Hospitalier de Roubaix', 'class': 'OTHER'}, {'name': 'Centre Hospitalier de Lens', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}