Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT05734404
Status:
RECRUITING
Last Update Posted:
2025-02-28
First Post:
2023-02-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Longitudinal Study for Central Nervous System Vasculitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020293', 'term': 'Vasculitis, Central Nervous System'}, {'id': 'D014657', 'term': 'Vasculitis'}], 'ancestors': [{'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-25', 'studyFirstSubmitDate': '2023-02-08', 'studyFirstSubmitQcDate': '2023-02-08', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the pathogenesis of central nervous system vasculitis using disease history.', 'timeFrame': 'Study completion; from baseline through month 36.', 'description': 'To study the manner of development of disease in patients affected with central nervous system vasculitis.'}], 'secondaryOutcomes': [{'measure': 'PROMIS Questionnaires', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36', 'description': 'Questions will ask about Cognition function on the PROMIS short form.'}, {'measure': 'PROMIS Questionnaires', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36', 'description': 'Questions will ask about depression on the PROMIS short form.'}, {'measure': 'PROMIS Questionnaires', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36', 'description': 'Questions will ask about fatigue on the PROMIS short form.'}, {'measure': 'PROMIS Questionnaires', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36', 'description': 'Questions will ask about Ability to participate in social roles and activities on the PROMIS short form.'}, {'measure': 'PROMIS Questionnaires', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36', 'description': 'Questions will ask about Upper extremity function on the PROMIS short form.'}, {'measure': 'PROMIS Questionnaires', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36', 'description': 'Questions will ask about lower extremity function on the PROMIS short form.'}, {'measure': 'PROMIS Questionnaires', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36', 'description': 'Questions will ask about Global Health (physical) on the PROMIS short form.'}, {'measure': 'PROMIS Questionnaires', 'timeFrame': 'Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36', 'description': 'Questions will ask about Global Health (mental) on the PROMIS short form.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Nervous System Vasculitis', 'CNS Vasculitis', 'CNSV', 'Vasculitis']}, 'descriptionModule': {'briefSummary': 'Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. The purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in CNSV.', 'detailedDescription': 'Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. Originally described in the early 1950s, research in the disease has been slow to progress, largely limited by the rarity of the disease and the lack of biologic materials for basic and translational investigations. To date, the bulk of research in the field has been clinical, largely consisting of retrospective case series, predominately from single sites, focusing on correlations among clinical, imaging, and histopathology data. Collectively these series suggest the existence of clinically-relevant subsets. Such studies, while enhancing our knowledge of this rare disease, are limited by small numbers of patients (especially those confirmed by histopathology), and the near absence of detailed investigations into the biomolecular and immunopathogenic basis of the disease.\n\nDevelopment of this longitudinal cohort and multicenter approach offers the potential to generate new insights, generate new questions, and further our understanding of its natural history, pathophysiology, genetic basis, and discovery of biomarkers to assess disease activity and prognosis.\n\nStudy visits will occur every 3 months for this first year, and then annually for two more years. Blood collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Individuals with central nervous system vasculitis (CNSV). Enrollment will be sequential and participants will have disease in various stages and of different duration.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ni. Diagnostic criteria for CNSV\n\n1. The presence of an acquired and otherwise unexplained neurologic deficit\n2. The presence of either classic angiographic or histopathologic features of angiitis in the CNS\n3. No evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features\n\nii. ≥18 years of age\n\nExclusion Criteria:\n\ni. Unwilling to sign informed consent.'}, 'identificationModule': {'nctId': 'NCT05734404', 'briefTitle': 'Longitudinal Study for Central Nervous System Vasculitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Pennsylvania'}, 'officialTitle': 'Longitudinal Study for Central Nervous System Vasculitis', 'orgStudyIdInfo': {'id': 'VCRC5509'}}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Wiecek', 'role': 'CONTACT', 'email': 'WIECEKA2@ccf.org'}], 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Daniel Killion', 'role': 'CONTACT', 'email': 'dkillion@pennmedicine.upenn.edu'}], 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Pamela Krueger', 'role': 'CONTACT', 'email': 'pamela.krueger@vumc.org'}], 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Hamilton', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Sandra Messier', 'role': 'CONTACT', 'email': 'smessier@stjosham.on.ca'}], 'facility': "St. Joseph's Healthcare", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Toronto', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Nazrana Haq', 'role': 'CONTACT', 'email': 'Nazrana.Haq@sinaihealth.ca'}], 'facility': 'University of Toronto/Sinai Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Carol McAlear', 'role': 'CONTACT', 'email': 'cmcalear@upenn.edu', 'phone': '7813214567'}], 'overallOfficials': [{'name': 'Rula Hajj-Ali, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Leonard Calabrese, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}, {'name': 'Peter Merkel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pennsylvania'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pennsylvania', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Cleveland Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}