Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-28 @ 9:17 AM
Study NCT ID:
NCT01260532
Status:
UNKNOWN
Last Update Posted:
2010-12-15
First Post:
2010-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association of Costimulatory Molecules and PPAR-polymorphisms With Autoimmune Thyroid Disease in Taiwan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-12-13', 'studyFirstSubmitDate': '2010-12-13', 'studyFirstSubmitQcDate': '2010-12-13', 'lastUpdatePostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Autoimmune thyroid disease'], 'conditions': ['AITd Patients With Different Polymorphisms']}, 'descriptionModule': {'briefSummary': "Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD include Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD remains unclear, it is generally thought that the mechanisms of the disease is a complex disease in which susceptibility genes and environmental triggers act in concert to initiate the autoimmune response to the thyroid.\n\nThe initial step of thyroid autoimmunity is the activation of T cells. The activation of T cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells is also required the interaction of costimulatory molecules between thyroid follicular cells and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear transcription factor, associated with adipogenesis and inflammation. Some reports showed that PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.\n\nThe goal of the study is to investigate the relationship among SNP and mRNA of costimulatory molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and PPAR- polymorphism in AITD.", 'detailedDescription': "Autoimmune thyroid disease is the most common organ-specific autoimmune disease. AITD include Graves' disease and Hashimoto's thyroiditis. Although the pathogenesis of AITD remains unclear, it is generally thought that the mechanisms of the disease is a complex disease in which susceptibility genes and environmental triggers act in concert to initiate the autoimmune response to the thyroid.\n\nThe initial step of thyroid autoimmunity is the activation of T cells. The activation of T cell requires two signals: firstly, thyroid follicular cells or antigen presenting cells binds to T cell receptor through antigenic HLA complex. Secondly, the activation of T cells is also required the interaction of costimulatory molecules between thyroid follicular cells and immune cells, including CTLA-4, CD 40, CD28, ICOS. PPAR- is a kind of intranuclear transcription factor, associated with adipogenesis and inflammation. Some reports showed that PPAR- polymorphism may have a protective effect from Graves' ophthalmopathy.\n\nThe goal of the study is to investigate the relationship among SNP and mRNA of costimulatory molecules and PPAR- , serum cytokine including TNF- and sIL-2R, and clinical characteristics in AITD patients. From the study, we hope to clarify the role of costimulatory molecules and PPAR- polymorphism in AITD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Autoimmune thyroid patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Autoimmune thyroid patients\n* patients who cut Nodular Goiter in Wanfang Hospital\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT01260532', 'briefTitle': 'The Association of Costimulatory Molecules and PPAR-polymorphisms With Autoimmune Thyroid Disease in Taiwan', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University WanFang Hospital'}, 'officialTitle': 'The Association of Costimulatory Molecules and PPAR-polymorphisms With Autoimmune Thyroid Disease in Taiwan', 'orgStudyIdInfo': {'id': '98049'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Graves' disease", 'description': 'no intervention'}, {'label': "Hashimoto's thyroiditis", 'description': 'no intervention'}, {'label': 'Healthy subjects', 'description': 'no intervention'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Medical University - WanFang Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Jiunn-Diann Lin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Taipei Medical University WanFang Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University WanFang Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Jiunn-Diann Lin', 'oldOrganization': 'Division of Endocrinology and Metabolism'}}}}