Ignite Creation Date:
2025-12-24 @ 5:05 PM
Ignite Modification Date:
2025-12-27 @ 1:14 PM
Study NCT ID:
NCT04510350
Status:
COMPLETED
Last Update Posted:
2022-03-03
First Post:
2020-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2020-08-10', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of immune subpopulations', 'timeFrame': '1 year', 'description': 'Correlations between the frequency of immune subpopulations, genetic profile and disease activity'}], 'secondaryOutcomes': [{'measure': 'Frequency of immune subpopulations correlated to EDSS score', 'timeFrame': '1 year', 'description': 'Correlations between the frequency of immune subpopulations, genetic profile, and EDSS score ((Expanded Disability Status Scale, method of quantifying disability in multiple sclerosis, steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.)'}, {'measure': 'Frequency of immune subpopulations correlated to disease progression delay', 'timeFrame': '1 year', 'description': 'Correlations between the frequency of immune subpopulations, genetic profile, and delay before disease progression'}, {'measure': 'Frequency of immune subpopulations correlated to disease progression events', 'timeFrame': '1 year', 'description': 'Correlations between the frequency of immune subpopulations, genetic profile, and number of disease progression events'}, {'measure': 'Frequency of immune subpopulations correlated to spinal lesions', 'timeFrame': '1 year', 'description': 'Correlations between the frequency of immune subpopulations, genetic profile, and number of new spinal lesions'}, {'measure': 'Profiles of CIS+ patients', 'timeFrame': '1 year', 'description': 'Comparison of genetic and immunological profiles of CIS+ patients with healthy volunteers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'After selection of the patients and volunteers of interest (number and type of clinical and biological data available, heterogeneity of the chosen group...), the medical and imaging data of the patients will be transmitted by OFSEP from the EDMUS database and for healthy volunteers, the data of interest will be retrieved from the ABCD-SEP database\n\nPatients CIS+ :60 Healthy Volunters : 30', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients :\n\nInclusion Criteria:\n\n* Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)\n* At least 18 years of age\n* Diagnosed with MS according to criteria 2017 at the time of their last visit.\n* Non-opposition to participation in the study\n* Having had at least one visit in the year following collection\n* Follow-up for at least 1 year after collection.\n* Having signed the OFSEP consent\n\nExclusion Criteria:\n\n* CIS patients with progressive MS\n\nHealthy volunteers :\n\nInclusion Criteria:\n\n* Age 18 years or older\n* Having participated in the ABCD-SEP clinical trial promoted by the Rennes University Hospital (NCT03744351).\n* Matched on age and sex to patients of interest in the OFSEP cohort\n* Not having objected to participation in the study\n\nExclusion Criteria:\n\n* Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty'}, 'identificationModule': {'nctId': 'NCT04510350', 'acronym': 'CISCO', 'briefTitle': 'Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)', 'organization': {'class': 'OTHER', 'fullName': 'Rennes University Hospital'}, 'officialTitle': 'Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)', 'orgStudyIdInfo': {'id': '35RC19_8880_CISCO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MS CIS+', 'interventionNames': ['Other: Biomarkers analysis']}, {'label': 'Healthy volunteers', 'interventionNames': ['Other: Biomarkers analysis']}], 'interventions': [{'name': 'Biomarkers analysis', 'type': 'OTHER', 'description': 'Genetic analysis of regions of interest', 'armGroupLabels': ['Healthy volunteers', 'MS CIS+']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rennes', 'country': 'France', 'facility': 'CHU Rennes', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}], 'overallOfficials': [{'name': 'Laure Michel, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rennes University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rennes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}