Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-04-25 @ 4:08 AM
Study NCT ID:
NCT03151902
Status:
COMPLETED
Last Update Posted:
2025-09-15
First Post:
2017-05-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Viral Particels in Urticaria Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080223', 'term': 'Chronic Urticaria'}], 'ancestors': [{'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-09', 'studyFirstSubmitDate': '2017-05-11', 'studyFirstSubmitQcDate': '2017-05-11', 'lastUpdatePostDateStruct': {'date': '2025-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-05-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'viral particles', 'timeFrame': '6 months', 'description': 'presence of viral particels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Urticaria Chronic']}, 'descriptionModule': {'briefSummary': 'Blood samples from urticaria patients will be analyzed for viral particles', 'detailedDescription': 'After digestion with DNase to eliminate human DNA, RNA will be reversed-transcribed and amplified with random primer/ Amplification products will be pooled and sequenced/ After substruction of sequences of vertebrates and highly repetitive sequences, contiguous sequences will be assembled and compared with motifs represented in databases of viruses. which will enable identification of putative protein sequences consistent with viruses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with chronic spontaneous urticaria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with chronic spontaneous urticaria\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03151902', 'briefTitle': 'Detection of Viral Particels in Urticaria Patients', 'organization': {'class': 'OTHER', 'fullName': 'HaEmek Medical Center, Israel'}, 'officialTitle': 'Detection of Viral Particels in Urticaria Patients', 'orgStudyIdInfo': {'id': 'HaEmekMC1'}}, 'contactsLocationsModule': {'locations': [{'zip': '1834111', 'city': 'Afula', 'country': 'Israel', 'facility': 'Emek Medical Center', 'geoPoint': {'lat': 32.60907, 'lon': 35.2892}}], 'overallOfficials': [{'name': 'Menachem Rottem', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'haemek medical center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'HaEmek Medical Center, Israel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, Allergy Asthma and Immunology', 'investigatorFullName': 'Menachem Rottem', 'investigatorAffiliation': 'HaEmek Medical Center, Israel'}}}}