Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00737451
Status:
COMPLETED
Last Update Posted:
2012-03-27
First Post:
2008-06-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Association of Thyroid Autoimmunity and Chronic Urticaria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011537', 'term': 'Pruritus'}, {'id': 'D000080223', 'term': 'Chronic Urticaria'}, {'id': 'D014581', 'term': 'Urticaria'}, {'id': 'D006042', 'term': 'Goiter'}], 'ancestors': [{'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'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': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 155}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-26', 'studyFirstSubmitDate': '2008-06-30', 'studyFirstSubmitQcDate': '2008-08-18', 'lastUpdatePostDateStruct': {'date': '2012-03-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The prevalence of thyroid autoimmunity in chronic urticaria in Taiwan', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['urticaria', 'goiter'], 'conditions': ['Skin Itching', 'Chronic Urticaria']}, 'descriptionModule': {'briefSummary': 'Increase prevalence of thyroid autoimmunity is found in patients with chronic urticaria. About 5-34% of chronic urticaria patients is associated with the presence of thyroid autoimmunity who are euthyroid status whereas 5-10% of them with either hyperthyroidism or hypothyroidism.', 'detailedDescription': 'There is no such report on the association of thyroid autoantibodies and chronic urticaria in Taiwan population yet. This study is designed to investigate the prevalence of thyroid autoimmunity associated with chronic urticaria in Taiwanese population. In addition, we intend to find out the change in the level of thyroid autoimmunity after the treatment in order to further understand their relationship. We also intend to find out the prognostic parameters in patients with the presence of thyroid autoimmunity and chronic urticaria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 and above with complaint of skin itching', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years old and above\n* skin itching for more than 6 months\n\nExclusion Criteria:\n\n* pure physical urticaria, infectious diseases, and food or food addictive hypersensitivity, chronic infection'}, 'identificationModule': {'nctId': 'NCT00737451', 'briefTitle': 'Association of Thyroid Autoimmunity and Chronic Urticaria', 'organization': {'class': 'OTHER', 'fullName': 'Far Eastern Memorial Hospital'}, 'officialTitle': 'Association of Thyroid Autoimmunity and Chronic Urticaria in Taiwan', 'orgStudyIdInfo': {'id': '96051'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'skin itching', 'interventionNames': ['Behavioral: blood sampling']}], 'interventions': [{'name': 'blood sampling', 'type': 'BEHAVIORAL', 'description': 'blood sampling 10ml from the study subjects', 'armGroupLabels': ['skin itching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '22060', 'city': 'Banqiao District', 'state': 'Taipei', 'country': 'Taiwan', 'facility': 'Far Eastern Memorial Hospital', 'geoPoint': {'lat': 25.01427, 'lon': 121.46719}}], 'overallOfficials': [{'name': 'Jiang Ju Ying, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Far Eastern Memorial Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Far Eastern Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending physician', 'investigatorFullName': 'Ju-Ying Jiang', 'investigatorAffiliation': 'Far Eastern Memorial Hospital'}}}}