Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT04713293
Status:
RECRUITING
Last Update Posted:
2021-01-19
First Post:
2020-12-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
China Pituitary Disease Registry (CAPASITY)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010900', 'term': 'Pituitary Diseases'}, {'id': 'D010911', 'term': 'Pituitary Neoplasms'}], 'ancestors': [{'id': 'D007027', 'term': 'Hypothalamic Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D007029', 'term': 'Hypothalamic Neoplasms'}, {'id': 'D015173', 'term': 'Supratentorial Neoplasms'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-14', 'studyFirstSubmitDate': '2020-12-31', 'studyFirstSubmitQcDate': '2021-01-14', 'lastUpdatePostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'percentage of functional pituitary adenoma', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'percentage of PRLoma, GHoma, ACTHoma, and etc'}, {'measure': 'remission and recurrence rate of pituitary surgery', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'treatment outcome of pituitary adenoma. Results will be dichotomized as remission, persistence or recurrence.'}], 'secondaryOutcomes': [{'measure': 'concentration of GH', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in GH'}, {'measure': 'concentration of IGF-1', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in IGF-1'}, {'measure': 'concentration of PRL', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in PRL'}, {'measure': 'concentration of ACTH', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in ACTH'}, {'measure': 'concentration of cortisol', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in cortisol'}, {'measure': 'concentration of fT3', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in fT3'}, {'measure': 'concentration of fT4', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in fT4'}, {'measure': 'concentration of TSH', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in TSH'}, {'measure': 'pituitary MRI', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'changes in MRI of sellar area'}, {'measure': 'percentage of hypopituitarism', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'percentage of hypopituitarism'}, {'measure': 'percentage of diabetes insipidus, etc', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'percentage of diabetes insipidus, etc'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pituitary Disease', 'Pituitary Adenoma'], 'conditions': ['Pituitary Disease']}, 'descriptionModule': {'briefSummary': 'Epidemiologic studies have revealed a tremendous increase in the prevalence of pituitary disease and related mortality worldwide. In order to meet all the challenges in the treatment of pituitary disease in China, CAPASITY was founded in 2020. The objective of CAPASITY is to launch a pituitary disease management model based on the Internet health information platform. It allows the application and evaluation of pituitary disease treatment strategies at multiple centers. The proprietary electronic medical database will help the dynamic big-data analysis in epidemiology of pituitary disease, diagnosis, and treatment.', 'detailedDescription': "In order to meet all the challenges in the diagnosis and treatment of pituitary diseases in China, CAPASITY was founded in 2020. With advanced medical equipment and Internet of Things (IoT) technology, CAPASITY is committed to creating an online and offline integrated solution for pituitary disease, and for the entire spectrum of pituitary disease, to achieve a more convenient and precise model of care for patients. aiming to establish a platform with diagnosis and treatment of pituitary disease and their long-term follow-up. It allows the application and evaluation of treatment strategies at these centers.\n\nObjective:\n\n* The purpose of the present study is to establish a multi-center nationwide prospective database of patients with pituitary adenomas to explore the epidemiology, biochemical, and clinical outcome related to pituitary tumors and its complications, as well as other pituitary disease.\n* To collect cross-sectional data from patients seen and treated at each center so as to evaluate: the current status of care of patients with pituitary disease and its related complications, as well as other risk factors treatment strategies at multiple centers.\n* To collect the prospective data of patients treated at each center in order to evaluate the strategies for the achievement of treatment goals, changes in management, control of risk factors, incidence and progression of related clinical endpoints (including mortality), behavioral changes, as well as QoL.\n\nMethods: After obtaining informed consent, patients will be invited and initiated with a comprehensive baseline evaluation at each CAPASITY center. Then patients will be followed by clinical/laboratory visits on according to individualized patient's treatment plans. A repeated comprehensive clinical and laboratory assessment for hormones and imaging, as well as complications will be scheduled once a year."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '14 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with pituitary disease', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years old and ≤ 75 years\n* Patients diagnosed with pituitary adenomas, and other pituitary diseases\n* Pituitary adenomas resected by transsphenoidal surgery were identified by histological diagnoses.\n* Gender: males and females\n* Provide written informed consent\n* Satisfactory compliance\n\nExclusion Criteria:\n\n* Patients with significantly reduced life expectancy (less than 2 years)\n* With Drug abuse\n* With AIDS or syphilis or infectious diseases such as viral tuberculosis in active phase at enrollment'}, 'identificationModule': {'nctId': 'NCT04713293', 'briefTitle': 'China Pituitary Disease Registry (CAPASITY)', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'China Pituitary Disease Registry Study', 'orgStudyIdInfo': {'id': '1.0/20200606'}}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weiqing Wang, Professor', 'role': 'CONTACT', 'email': 'wqingw61@163.com', 'phone': '008621-64370045', 'phoneExt': '671817'}], 'facility': 'National Metabolic Management center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Weiqing Wang, MD, PHD', 'role': 'CONTACT', 'email': 'wqingw61@163.com', 'phone': '008621-64370045', 'phoneExt': '671817'}], 'overallOfficials': [{'name': 'Weiqing Wang, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Metabolic Management center (Shanghai)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, MD, Head of Department of Endocrine and Metabolism, Shanghai Jiaotong University School of Medicine, Chinese National Clinical Research Center for Endocrine and Metabolic Diseases (Shanghai)', 'investigatorFullName': 'Wang Weiqing', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}