Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT03951818
Status:
UNKNOWN
Last Update Posted:
2021-02-18
First Post:
2019-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017086', 'term': 'beta-Thalassemia'}], 'ancestors': [{'id': 'D013789', 'term': 'Thalassemia'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-16', 'studyFirstSubmitDate': '2019-05-09', 'studyFirstSubmitQcDate': '2019-05-14', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abnormal bone mineral density rate', 'timeFrame': '10 years', 'description': 'abnormal bone mineral density is defined as T-score \\< -1 SD in menopause women or men older than 50 years old, or Z score \\< -2 SD in premenopausal women or men not older than 50 year old.'}], 'secondaryOutcomes': [{'measure': 'abnormal thyroid function rate', 'timeFrame': '10 years', 'description': 'abnormal thyroid function is defined as abnormal free thyroxine or abnormal thyrotropin. Normal range of free thyroxine is 0.6-1.75 ng/dl. normal range of thyrotropin is 0.1-4.5 mU/l.'}, {'measure': 'abnormal pituitary function rate', 'timeFrame': '10 years', 'description': 'abnormal pituitary function is defined as any of the abnormality in serum adrenocorticotropin (pg/l), IGF-1 (ng/ml). thyrotropin (mU/l), FSH (U/l), LH (U/l)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thalassemia Major']}, 'referencesModule': {'references': [{'pmid': '31907538', 'type': 'DERIVED', 'citation': 'Yang WP, Chang HH, Li HY, Lai YC, Huang TY, Tsai KS, Lin KH, Lin DT, Jou ST, Lu MY, Yang YL, Chou SW, Shih SR. Iron Overload Associated Endocrine Dysfunction Leading to Lower Bone Mineral Density in Thalassemia Major. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz309. doi: 10.1210/clinem/dgz309.'}]}, 'descriptionModule': {'briefSummary': 'Patient with thalassemia major have many endocrine diseases, such as hypopituitarism, hypothyroidism, hypoparathyroidis, osteoporosis, and etc.. These problems may be due to anemia itself or related to iron deposition. This study aimed to investigate the endocrine aspect of thalassemia major patients in Taiwan in order to introduce early intervention or treatment in the future.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '20-85 years old thalassemia major patients treated in the OPD of NTUH', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of Thalassemia major\n* Patients of 20-85 years old\n\nExclusion Criteria:\n\n* Patients younger than 20 years old.\n* Patients older than 85 years old.\n* Patients who are pregnant'}, 'identificationModule': {'nctId': 'NCT03951818', 'briefTitle': 'Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Observing the Changes of Endocrine and Metabolism in Patients With Thalassemia Major', 'orgStudyIdInfo': {'id': '201903041RINB'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shyang-Rong Shih', 'role': 'CONTACT', 'email': 'srshih@ntu.edu.tw', 'phone': '886-23123456'}], 'facility': 'Shyang-Rong Shih', '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}