Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-01-01 @ 9:59 AM
Study NCT ID:
NCT03853135
Status:
COMPLETED
Last Update Posted:
2020-01-06
First Post:
2019-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Endocan Serum Levels in Patients With Behcet Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001528', 'term': 'Behcet Syndrome'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D014606', 'term': 'Uveitis, Anterior'}, {'id': 'D015864', 'term': 'Panuveitis'}, {'id': 'D014605', 'term': 'Uveitis'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D056660', 'term': 'Hereditary Autoinflammatory Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-02', 'studyFirstSubmitDate': '2019-02-22', 'studyFirstSubmitQcDate': '2019-02-22', 'lastUpdatePostDateStruct': {'date': '2020-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "the Behcet's disease current activity form (BDCAF)", 'timeFrame': ': through study completion, an average of 6 months', 'description': 'One point is given to the presence of different organ involvement over the 4 weeks prior to assessment as follows: headache, mouth ulcers, genital ulcers, skin lesions , joint involvement , gastrointestinal symptoms , eye involvement , nervous system involvement , and major vessel involvement.The total score will be out of 12 and higher score indicates worse outcome. we will assess the relation between serum endocan level and BDCAF'}, {'measure': 'Erythrocyte sedimentation rate (ESR)', 'timeFrame': ': through study completion, an average of 6 months', 'description': 'ESR measured in mm/1st hour by westergren method. we will assess the relation between serum endocan level and ESR'}, {'measure': 'C reactive protein (CRP)', 'timeFrame': ': through study completion, an average of 6 months', 'description': 'CRP measured in mg/L using nephlometry. we will assess the relation between serum endocan level and CRP'}, {'measure': 'carotid intima media thickness', 'timeFrame': ': through study completion, an average of 6 months', 'description': 'Color Doppler ultrasonography was performed for both common carotid arteries in a longitudinal orientation and measured with millimeter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Behçet disease', 'endocan'], 'conditions': ['Behçet']}, 'descriptionModule': {'briefSummary': 'The aim of our study was to assess serum endocan levels in patients with Behcet disease and to correlate it with various disease clinical and laboratory parameters of disease activity as well as carotid intima media thickness.', 'detailedDescription': "This study will be carried out on two groups:\n\n• Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .\n\nGroup (II): including 42 age and sex matching healthy volunteers as control group.\n\n(A) Clinical evaluation\n\n1. Complete history taking.\n2. Thorough clinical examination including opthalmologic evaluation .\n3. Disease activity using The Behcet's disease current activity form (BD-DAF) . (B) Laboratory assessment:\n\nAll patients will be subjected to the following measurements:\n\n1. ESR\n2. CRP\n3. CBC\n4. liver and kidney function tests\n\nd) Serum Endocan level e)triglycrides f) cholestrol C) carotid intima media thickness"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This study will be carried out on two groups:\n\n• Group (I): Forty two patients diagnosed to have Behcets disease fulfilling the International Criteria for BD .\n\nGroup (II): including 42 age and sex matching healthy volunteers as control group.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with Behcets disease fulfilling the International Criteria for BD .\n\nExclusion Criteria:\n\n* infection\n* malignancy\n* other connective tissue disease\n* chronic liver disease\n* chronic kidney disease\n* Diabetes mellitus\n* hypertension\n* hyperlipidemia'}, 'identificationModule': {'nctId': 'NCT03853135', 'briefTitle': 'Assessment of Endocan Serum Levels in Patients With Behcet Disease', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Assessment of Endocan Serum Levels in Patients With Behcet Disease: Relation to Clinical Parameters and Disease Status', 'orgStudyIdInfo': {'id': 'BenhaU22019'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Behçet group', 'description': 'Forty two patients diagnosed to have Behçet disease fulfilling the International Study Group Criteria for Behçet disease in whom measurement of serum endocan levels will be performed.', 'interventionNames': ['Diagnostic Test: measurement of serum endocan']}, {'label': 'control group', 'description': 'including 42 age and sex matching healthy volunteers as control group in whom measurement of serum endocan levels will be performed.', 'interventionNames': ['Diagnostic Test: measurement of serum endocan']}], 'interventions': [{'name': 'measurement of serum endocan', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['endothelial cell-specific molecule 1'], 'description': 'measurement of serum levels of endocan', 'armGroupLabels': ['Behçet group', 'control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13518', 'city': 'Banhā', 'state': 'Qalyubia Governorate', 'country': 'Egypt', 'facility': 'Benha University Hospital', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}], 'overallOfficials': [{'name': 'Waleed Hassan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benha university- Qaluibya- Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Waleed Ahmed Salaheldeen Hassan', 'investigatorAffiliation': 'Benha University'}}}}