Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-28 @ 9:24 AM
Study NCT ID:
NCT06025903
Status:
RECRUITING
Last Update Posted:
2024-03-22
First Post:
2023-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Role of Mitochondrial Dysfunction in Primary Progressive 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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood and cerebrospinal fluid'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2023-08-29', 'studyFirstSubmitQcDate': '2023-08-29', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sequencing of mitochondrial DNA', 'timeFrame': '3 years', 'description': 'the mitochondrial DNA collected from blood and cerebrospinal fluid will be sequenced and analysed, comparing the frequency of variants between the two disease courses'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple sclerosis', 'mitochondria'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Specific aims are: 1) identify mitochondrial-related pathways, inherited and somatic mitochondrial DNA mutations associated to primary progressive multiple sclerosis, 2) functionally assess the identified genetic alterations.', 'detailedDescription': 'Multiple Sclerosis is a major cause of neurological disability, with a high socio-economic impact that increases as disability progresses. Effective treatment of primary progressive multiple sclerosis is still an unmet need and the underlying neurodegenerative processes have to be fully investigated. The purpose of this project is to study genetic determinants of mitochondrial impairment in primary progressive multiple sclerosis. Altered mitochondrial pathways will be investigate, as well as inherited and tissue-specific somatic mitochondrial variations associated with primary progressive multiple sclerosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients will be recruited from primary care clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients affected by primary progressive or relapsing remitting multiple sclerosis\n* Patient able to provide informed consent\n\nExclusion Criteria:\n\n* Individuals with \\< 18 years\n* Patients not affected by primary progressive or relapsing remitting multiple sclerosis'}, 'identificationModule': {'nctId': 'NCT06025903', 'briefTitle': 'Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS San Raffaele'}, 'officialTitle': 'Assessing the Role of Mitochondrial Dysfunction in Primary Progressive Multiple Sclerosis', 'orgStudyIdInfo': {'id': 'MitoMS_GR-2019-12368672'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Primary Progressive multiple sclerosis', 'description': 'patients affected by primary progressive multiple sclerosis'}, {'label': 'Relapsing Remitting multiple sclerosis', 'description': 'patients affected by primary progressive multiple sclerosis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20132', 'city': 'Milan', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Esposito', 'role': 'CONTACT', 'email': 'esposito.federica@hsr.it'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'zip': '21013', 'city': 'Gallarate', 'state': 'VA', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Clara Guaschino', 'role': 'CONTACT', 'email': 'clara.guaschino@asst-valleolona.it'}], 'facility': 'ASST della Valle Olona - Ospedale di Gallarate', 'geoPoint': {'lat': 45.66019, 'lon': 8.79164}}], 'centralContacts': [{'name': 'Federica Esposito', 'role': 'CONTACT', 'email': 'esposito.federica@hsr.it', 'phone': '0226437833'}], 'overallOfficials': [{'name': 'Melissa Sorosina', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS San Raffaele'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS San Raffaele', 'class': 'OTHER'}, 'collaborators': [{'name': 'Azienda Socio Sanitaria Territoriale della Valle Olona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Melissa Sorosina', 'investigatorAffiliation': 'IRCCS San Raffaele'}}}}