Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT04075851
Status:
UNKNOWN
Last Update Posted:
2021-04-14
First Post:
2019-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050031', 'term': 'Hashimoto Disease'}], 'ancestors': [{'id': 'D013967', 'term': 'Thyroiditis, Autoimmune'}, {'id': 'D013966', 'term': 'Thyroiditis'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2019-08-29', 'studyFirstSubmitQcDate': '2019-08-29', 'lastUpdatePostDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of thyroid hormone autoantibodies in AITD', 'timeFrame': 'measured after 1 year of follow-up', 'description': 'Radioimmuno precipitation test used for thyroid hormone autoantibodies'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autoimmune thyroid disease', 'Thyroid hormone autoantibodies', "Hashimoto's thyroiditis", "Grave's disease"], 'conditions': ['Autoimmune Thyroid Disease']}, 'descriptionModule': {'briefSummary': 'Thyroid hormone autoantibodies(THAA) in serum can Interfere radioimmunoassay for the determination of free thyroid hormones. Thyroid function test plays a key role in the diagnosis and treatment of autoimmune thyroid disease (AITD), and abnormal examination results in misdiagnosis and mistreatment. At present, the epidemiological results of THAA in AITD are inconsistent, and the pathogenesis has not been clarified. However, there is no relevant research on THAA in China. This project intends to collect AITD patients and healthy people, detecting THAA, at the same time testing thyroid function and thyroid autoantibodies, definiting positive rate of THAA in AITD patients, observing the effect of common therapeutic drugs for AITD on THAA, investigating the rule of THAA influencing thyroid function test results .This project will provide the basis and method for how to effectively avoid THAA interfering with thyroid function test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Autoimmune thyroid diseases in endocrine outpatient department of shandong provincial hospital from August 1, 2019 to August 1, 2022', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* male or female with Hashimoto thyroiditis or Grave's disease aged for 18 to 65 years old\n\nExclusion Criteria:\n\n* Had a thyroidectomy Had a thyroid fine needle puncture biopsy Autoimmune diseases Take drugs that affect the immune system"}, 'identificationModule': {'nctId': 'NCT04075851', 'briefTitle': 'The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Shandong Provincial Hospital'}, 'officialTitle': 'The Prevalence of Serum Thyroid Hormone Autoantibodies in Autoimmune Thyroid Diseases', 'orgStudyIdInfo': {'id': '20190801'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Hashimoto or Grave's disease patients in treatment", 'description': 'Draw 10 ml venous blood'}, {'label': "Hashimoto or Grave's disease patients on initial treatment", 'description': '10 ml of venous blood was extracted every month for three months'}, {'label': "Pregnant woman with Hashimoto or Grave's disease", 'description': '10 ml venous blood was extracted every month to postpartum for 6 months'}, {'label': 'Healthy crowd', 'description': 'Draw 10 ml venous blood'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250021', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Haiqing Zhang', 'role': 'CONTACT', 'email': '15168888303@163.com', 'phone': '86-53-68776094'}], 'facility': 'Shandong Province Hospital', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Ling Gao', 'role': 'CONTACT', 'email': 'gaoling1@medmall.com.cn', 'phone': '+86 53168776910'}], 'overallOfficials': [{'name': 'Haiqing Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'shandong province hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong Provincial Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hai-qing Zhang', 'investigatorAffiliation': 'Shandong Provincial Hospital'}}}}