Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2026-01-22 @ 1:48 PM
Study NCT ID:
NCT02883335
Status:
RECRUITING
Last Update Posted:
2023-02-08
First Post:
2016-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lorraine Registry of Multiple Sclerosis
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6000}, 'targetDuration': '30 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-06', 'studyFirstSubmitDate': '2016-08-19', 'studyFirstSubmitQcDate': '2016-08-25', 'lastUpdatePostDateStruct': {'date': '2023-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2030-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'case occurence of multiple sclerosis', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'EDSS score', 'timeFrame': '30 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '23816638', 'type': 'BACKGROUND', 'citation': 'Brissart H, Morele E, Baumann C, Perf ML, Leininger M, Taillemite L, Dillier C, Pittion S, Spitz E, Debouverie M. Cognitive impairment among different clinical courses of multiple sclerosis. Neurol Res. 2013 Oct;35(8):867-72. doi: 10.1179/1743132813Y.0000000232. Epub 2013 Jun 19.'}, {'pmid': '21071951', 'type': 'BACKGROUND', 'citation': 'Brissart H, Sauvee M, Latarche C, Dillier C, Debouverie M. Integration of cognitive impairment in the expanded disability status scale of 215 patients with multiple sclerosis. Eur Neurol. 2010;64(6):345-50. doi: 10.1159/000322140. Epub 2010 Nov 13.'}, {'pmid': '22354740', 'type': 'RESULT', 'citation': 'El Adssi H, Debouverie M, Guillemin F; LORSEP Group. Estimating the prevalence and incidence of multiple sclerosis in the Lorraine region, France, by the capture-recapture method. Mult Scler. 2012 Sep;18(9):1244-50. doi: 10.1177/1352458512437811. Epub 2012 Feb 21.'}, {'pmid': '25966681', 'type': 'RESULT', 'citation': 'Becker M, Latarche C, Roman E, Debouverie M, Malaplate-Armand C, Guillemin F. No prognostic value of routine cerebrospinal fluid biomarkers in a population-based cohort of 407 multiple sclerosis patients. BMC Neurol. 2015 May 13;15:79. doi: 10.1186/s12883-015-0330-4.'}]}, 'descriptionModule': {'briefSummary': 'The RelSEP aims to register exhaustively every new case of multiple sclerosis (MS) occuring in Lorraine a French region, and follow up on them for an indefinite duration, registering disease evolution and intercurrent events.', 'detailedDescription': 'As every patient registry in France, the RelSEP is periodically (every four years) evaluated by an independent committee.\n\nThe RelSEP interrogate multiple sources to insure its exhaustiveness :\n\n* every neurologists of Lorraine\n* MS patient network in Lorraine\n* health insurance data\n* PMSI (administrative French national database for hospitals)\n* biological and imagery services in Lorraine Procedures (automatic and manual) are used to eliminate duplicates Once a patient has been identified its medical file are checked by investigators in order to retrieve the relevant information.\n\nNew MS cases are confirmed by neurologists. Automatics (implemented in EDMUS software)and manual checks are implemented in the registry database, looking for inconsistencies.\n\nThe following data are registered :\n\n* Name, birthname\n* Sex\n* Date of birth\n* Location (town)\n* Birth location (town)\n* Profession\n* Number of siblings\n* Marital status\n* Number of children\n* Date of onset\n* Date and nature of clinical manifestations\n* MRI reports\n* CSF analysis reports\n* Event-related potential reports\n* Impairment and disability evolution\n* Treatments (start and change of drug treatment)\n* Drugs related events\n* Cause of treatment discontinuation\n* Disease progression Every case has a follow up at least every two years.\n\nThe quality of data is evaluated by periodically auditing cases at random from our database.\n\nAn annual report on the main data (incidence and prevalence) of MS in Lorraine is produced.\n\nData are also used for observational studies on prognostic factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffering from multiple sclerosis in Lorraine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Having a confirmed multiple sclerosis diagnosis\n* Living in Lorraine (French region)\n\nExclusion Criteria:\n\n* Refusal to be registered'}, 'identificationModule': {'nctId': 'NCT02883335', 'acronym': 'RelSEP', 'briefTitle': 'Lorraine Registry of Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Lorraine Registry of Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'RELSEP'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational registry', 'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jonathan Epstein, MD, MSc', 'role': 'CONTACT', 'email': 'j.epstein@chru-nancy.fr'}], 'facility': 'CIC 1433 Épidémiologie clinique, Inserm, Université de Lorraine, CHRU de Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'centralContacts': [{'name': 'Francis Guillemin, MD, PHD', 'role': 'CONTACT', 'email': 'francis.guillemin@chru-nancy.fr'}, {'name': 'Jonathan Epstein, MD, MSc', 'role': 'CONTACT', 'email': 'j.epstein@chru-nancy.fr'}], 'overallOfficials': [{'name': 'Francis Guillemin, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHRU Nancy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'open to partnership'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'University of Lorraine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Médecine coordonateur de module', 'investigatorFullName': 'GUILLEMIN Francis, MD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}