Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT01238003
Status:
UNKNOWN
Last Update Posted:
2010-11-10
First Post:
2010-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Relevance of Anti-Neutrophil Cytoplasm Antibody (ANCA)in Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 380}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-11-09', 'studyFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2010-11-09', 'lastUpdatePostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mostly negative lab results', 'timeFrame': 'One year'}]}, 'conditionsModule': {'conditions': ['ANCA-related Vasculitis']}, 'descriptionModule': {'briefSummary': 'Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that when this lab test is performed on blood of patients who do not have a high level of suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there are many false positive results. Because of this, it should not be used as a screening test for a more general patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients hospitalized in internal medicine ward', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Blood samples sent for ANCA lab test\n\nExclusion Criteria:\n\n* Patients with ANCA vasculitis\n* Patients with known malignancy'}, 'identificationModule': {'nctId': 'NCT01238003', 'briefTitle': 'Clinical Relevance of Anti-Neutrophil Cytoplasm Antibody (ANCA)in Hospitalized Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'orgStudyIdInfo': {'id': 'HYMC-10-0087'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Hospitalized patients', 'interventionNames': ['Other: Interpretation of blood test results']}], 'interventions': [{'name': 'Interpretation of blood test results', 'type': 'OTHER', 'description': 'Interpretation of blood test results', 'armGroupLabels': ['Hospitalized patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hadera', 'country': 'Israel', 'facility': 'Hillel Yaffe MC,', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Nina Avshovich, MD', 'role': 'CONTACT', 'email': 'ninaa@hy.health.gov.il', 'phone': '972-52-5566049'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Dr. Nina Avshovich', 'oldOrganization': 'Hillel Yaffe Medical Center'}}}}