Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT05578105
Status:
RECRUITING
Last Update Posted:
2022-10-13
First Post:
2022-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016884', 'term': 'Polyendocrinopathies, Autoimmune'}], 'ancestors': [{'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 650}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-10-10', 'studyFirstSubmitDate': '2022-10-10', 'studyFirstSubmitQcDate': '2022-10-10', 'lastUpdatePostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of endocrine organs involved', 'timeFrame': '2022/1/1 ~ 2026/12/31', 'description': 'We will observe the rate of each endocrine organ involved, including adrenal gland, thyroid, and pancreas'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Autoimmune Polyendocrine Syndrome Type II']}, 'descriptionModule': {'briefSummary': 'Autoimmune polyendocrine syndrome (APS) is an autoimmune disease involving at least two endocrine organ. It is classified into type I and type II diseases. Among them, APS type II is more common. It is diagnosed when two of the three following diseases are diagnosed in the same patient, including type 1 diabetes mellitus, autoimmune thyroid disease, and primary adrenal insufficiency. In this study, we will observe the epidemiology, clinical characteristics, and genetic variants of APS II in Taiwan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'We study patients with autoimmune polyendocrine syndrome type II', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients visited NTUH during 2006-2021, and had at least two of the three diseases: type 1 DM, primary adrenal insufficiency, and autoimmune thyroid disease.\n\nExclusion Criteria:\n\n* Patients aged less than 20 years old'}, 'identificationModule': {'nctId': 'NCT05578105', 'briefTitle': 'Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Prevalence and Genetic Alternation of Autoimmune Polyglandular Syndrome Type II in Taiwan', 'orgStudyIdInfo': {'id': '202112250RINC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Autoimmune polyendocrine syndrome type II', 'description': 'patients with autoimmune polyendocrine syndrome type II', 'interventionNames': ['Other: no intervention']}], 'interventions': [{'name': 'no intervention', 'type': 'OTHER', 'description': 'No intervention, only observation', 'armGroupLabels': ['Autoimmune polyendocrine syndrome type II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shyang-Rong Shih, MD. PhD', 'role': 'CONTACT', 'email': 'srshih@ntu.edu.tw', 'phone': '+886-972653337'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Shyang-Rong Shih, MD, PhD', 'role': 'CONTACT', 'email': 'srshih@ntu.edu.tw', 'phone': '+886-972653337'}], 'overallOfficials': [{'name': 'Shyang-Rong Shih, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}