Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-29 @ 5:46 PM
Study NCT ID:
NCT01273792
Status:
UNKNOWN
Last Update Posted:
2021-07-29
First Post:
2011-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of Biomarkers in Susac Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055955', 'term': 'Susac Syndrome'}], 'ancestors': [{'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D015356', 'term': 'Retinal Artery Occlusion'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D005132', 'term': 'Eye Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples (serum, Blood cells)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-28', 'studyFirstSubmitDate': '2011-01-06', 'studyFirstSubmitQcDate': '2011-01-10', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'disease specific patterns of pathology on cranial MRI', 'description': 'one-time cranial MRI'}, {'measure': 'disease specific patterns of pathology in optical coherence tomography', 'description': 'one time optical coherence tomography'}, {'measure': 'serological biomarkers', 'timeFrame': 'not defined, cross-sectional analysis'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Susac Syndrome']}, 'referencesModule': {'references': [{'pmid': '19953118', 'type': 'BACKGROUND', 'citation': 'Dorr J, Radbruch H, Bock M, Wuerfel J, Bruggemann A, Wandinger KP, Zeise D, Pfueller CF, Zipp F, Paul F. Encephalopathy, visual disturbance and hearing loss-recognizing the symptoms of Susac syndrome. Nat Rev Neurol. 2009 Dec;5(12):683-8. doi: 10.1038/nrneurol.2009.176.'}]}, 'descriptionModule': {'briefSummary': 'Susac Syndrome is a rare disease and the establishment of the diagnosis is often difficult. The aim of this investigation is to identify relevant biomarkers and to elucidate the pathogenesis of Susac syndrome', 'detailedDescription': 'Susac Syndrome is a rare disease characterized by encephalopathy, branch retinal artery occlusion and sensorineural deafness. The pathogenesis is not yet clear, an autoimmune endotheliopathy is discussed. Because of the variable and often incomplete clinical presentation, the establishment of the diagnosis is often delayed or even completely missed.\n\nThe aim of this study is to identify biomarkers that facilitate the reliable and prompt establishment of the diagnosis. Patients with a definite diagnosis of Susac syndrome and healthy subjects as controls are investigated.\n\nFurthermore, the correlation of serological markers with structural retinal and cerebral changes will contribute to clarification of the pathogenesis of Susac syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with Susac syndrome (male/female; healthy control subjects', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult male and female patients with definite Susac syndrome or matching healthy control subjects\n* ability to provide informed consent\n\nExclusion Criteria:\n\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01273792', 'briefTitle': 'Investigation of Biomarkers in Susac Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Charite University, Berlin, Germany'}, 'officialTitle': 'Investigation of Relevant Biomarkers in Patients With Susac Syndrome', 'orgStudyIdInfo': {'id': 'Biomarkers Susac Syndrome'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with Susac syndrome'}, {'label': 'Matched healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jan M Dörr, MD', 'role': 'CONTACT', 'email': 'jan-markus.doerr@charite.de', 'phone': '+49 30 450', 'phoneExt': '660162'}, {'name': 'Jan M Dörr, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'NeuroCure Clinical Reserach Center, Charité Universitaetsmedizin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Jan M Dörr, MD', 'role': 'CONTACT', 'email': 'jan-markus.doerr@charite.de', 'phone': '+49 30 450', 'phoneExt': '660162'}], 'overallOfficials': [{'name': 'Jan M Dörr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NeuroCure Clinical Research Center, Charité Universitaetsmedizin Berlin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charite University, Berlin, Germany', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PD Dr. med.', 'investigatorFullName': 'Jan-Markus Dörr', 'investigatorAffiliation': 'Charite University, Berlin, Germany'}}}}