Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-01-03 @ 12:37 PM
Study NCT ID:
NCT06570967
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2024-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Study of Hyperthyroidism in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006980', 'term': 'Hyperthyroidism'}], 'ancestors': [{'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-07-18', 'size': 144212, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-08-22T01:18', 'hasProtocol': True}, {'date': '2023-07-18', 'size': 165310, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-08-22T01:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-24', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-22', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Remission of hyperthyroidism in children treated with methimazole. Remission is defined as having clinical and biochemical euthyroidism(FT3, FT4 and TSH are normal) without methimazole treatment for at least 12 months.', 'timeFrame': '10 years', 'description': 'To analyze the therapeutic effect of methimazole and the predictors of remission of hyperthyroidism after methimazole treatment.'}, {'measure': 'Adverse effects of methimazole in the treatment of hyperthyroidism in children. Adverse effects are defined as having neutropenia (absolute neutrophil count< 1500/µL), liver dysfunction (AST or ALT> 60 IU/L), rash, arthralgia, myalgia, et al.', 'timeFrame': '1 year', 'description': 'Analyze the adverse reaction of methimazole treatment in hyperthyroidism children. Explore the risk factors related to the occurrence of methimazole related adverse reactions.'}], 'secondaryOutcomes': [{'measure': 'Relapse of hyperthyroidism in children treated with methimazole. Relapse was defined as having clinical and biochemical hyperthyroidism (FT3 and FT4 increased and TSH decreased) after discontinuation of methimazole.', 'timeFrame': '10 years', 'description': 'The risk factors of relapse in children with hyperthyroidism treated with MMI were analyzed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hyperthyroidism']}, 'descriptionModule': {'briefSummary': 'This study intends to conduct a retrospective and prospective study on children with hyperthyroidism, and it is a non-intervention study to collect information on diagnosis and treatment and long-term follow-up of children with hyperthyroidism. To investigate the clinical characteristics, treatment effect, side effects and remission of hyperthyroidism in children, to analyze the predictive factors for the effect of antithyroid drug treatment, remission and recurrence after drug withdrawal, and to explore the risk factors related to the occurrence of antithyroid drug-related adverse reactions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '29 Days', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population included male and female with hyperthyroidism aged no more than 14 years. Participants must have not been treated with medication in other hospitals, have no history of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation, and have complete clinical data.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≤14 years old\n2. Initial diagnosis of hyperthyroidism\n\nExclusion Criteria:\n\n1. Hyperthyroidism had been treated with medication in other hospitals,\n2. History of autoimmune hepatitis, viral hepatitis, hematological diseases, bone marrow or liver transplantation,\n3. Patients with incomplete clinical data'}, 'identificationModule': {'nctId': 'NCT06570967', 'briefTitle': 'A Clinical Study of Hyperthyroidism in Children', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'A Retrospective and Prospective Observational Study of Hyperthyroidism in Children', 'orgStudyIdInfo': {'id': '1223'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Methimazole(MMI)', 'type': 'DRUG', 'description': 'The initial dose of methimazole was 0.2-0.8 mg/(kg▪d). This dose was subsequently reduced by 25% to 50% and adjusted to maintain euthyroidism, based on the results of serum thyroid hormone testing during follow-up.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Xin, Doctor', 'role': 'CONTACT', 'email': 'xin.ying168@live.cn', 'phone': '+8618940251876'}], 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'centralContacts': [{'name': 'Shi Tang, Doctor', 'role': 'CONTACT', 'email': 'ts047827@163.com', 'phone': '+8618940259064'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shengjing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Shi Tang', 'investigatorAffiliation': 'Shengjing Hospital'}}}}