Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT06229405
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-01-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}, {'id': 'D006929', 'term': 'Hyperaldosteronism'}, {'id': 'D003480', 'term': 'Cushing Syndrome'}, {'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D018268', 'term': 'Adrenocortical Carcinoma'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D000308', 'term': 'Adrenocortical Hyperfunction'}, {'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D000306', 'term': 'Adrenal Cortex Neoplasms'}, {'id': 'D000303', 'term': 'Adrenal Cortex Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum/Buffy coat to discover prognostic biomarkers and genetic background'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8200}, 'targetDuration': '20 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-29', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-19', 'lastUpdatePostDateStruct': {'date': '2024-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rate of cardiovascular event', 'timeFrame': 'up to 20years', 'description': 'Cardiovascular event'}], 'secondaryOutcomes': [{'measure': 'Mortality rate', 'timeFrame': 'up to 20years', 'description': 'Mortality'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adrenal Tumor', 'Primary Aldosteronism', 'Cushing Syndrome', 'Pheochromocytoma', 'Adrenal Cortical Carcinoma']}, 'descriptionModule': {'briefSummary': 'This research aims to establish clinical evidence for optimal treatment guidelines for adrenal diseases using real-world data. The approach involves building prospective and retrospective patient registries, which will be utilized to develop and conduct research on disease-specific protocols for adrenal disorders. The study targets patients with primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion. Registries for patients with adrenal diseases will be obtained from Seoul National University Hospital and Asan Medical Center, along with securing a common data model. The ultimate goal is to conduct research to generate clinical evidence for adrenal diseases using these resources.', 'detailedDescription': 'The ultimate goal is to develop clinical evidence for unmet needs in adrenal gland diseases using real-world data, thereby contributing to the optimization of treatment guidelines. This involves:\n\n1. Generating real-world healthcare data through prospective and retrospective registries specific to each adrenal disease.\n2. Acquiring a common data model for adrenal diseases, applicable across both domestic and international multicenter settings.\n3. Creating real-world data linked with hospital medical records and public data for each adrenal disease, utilizing anonymized information merging services.\n4. Developing and conducting research based on prospective and retrospective registries, a common data model, and the utilization of public-medical data for different adrenal diseases.\n\nStudy Design:\n\nProspective and retrospective patient registries.\n\nStudy Population:\n\nPatients with adrenal gland disorders, including primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion\n\nResearch Methods:\n\n1. Securing prospective and retrospective registries of patients with adrenal diseases.\n2. Obtaining a common data model for adrenal diseases.\n3. Utilizing the secured registries and common data model for multicenter studies to generate clinical evidence for adrenal diseases.\n4. Linking public and medical data with the secured registries to further research in generating clinical evidence for adrenal diseases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with adrenal disorders', 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with adrenal diseases such as adrenal cortical carcinoma, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal incidentaloma\n* patients who are 19 years or older\n\nExclusion Criteria:\n\n* patients younger than 19 years old"}, 'identificationModule': {'nctId': 'NCT06229405', 'briefTitle': 'Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data: An Initiative by the Korean Adrenal Disorder Study (KADS) Group', 'orgStudyIdInfo': {'id': '2204-155-1320'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Nonfunctioning adrenal adenoma', 'description': 'Incidentally detected adrenal mass without hormone production'}, {'label': 'Mild autonomous cortisol secretion', 'description': "Adrenal tumors that do not meet the criteria for adrenal Cushing's syndrome but are not suppressed to below 1.8 µg/dL after the dexamethasone suppression test"}, {'label': 'Adrenal Cushing syndrome', 'description': 'Adrenal diseases characterized by biochemical hypercortisolism accompanying with overt Cushingoid features.'}, {'label': 'Primary aldosteronism', 'description': 'Adrenal diseases characterized by the excessive production of the hormone aldosterone and suppressed renin.\n\nDiagnostic criteria are as the following:\n\n1. Plasma aldosterone level of ≥6 ng/dL after a seated saline infusion test\n2. Plasma aldosterone level of ≥13 ng/dL after a captopril challenge test.'}, {'label': 'Pheochromocytoma and paraganglioma', 'description': 'Chromaffin-originated tumors in the adrenal gland and others, characterized by catecholamine excess'}, {'label': 'Adrenal cortical carcinoma', 'description': 'Malignant tumors originated from the adrenal cortex, which was confirmed by biopsy or pathology results'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jung Hee Kim, M.D', 'role': 'CONTACT', 'email': 'jhkxingfu@gmail.com'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Jung Hee Kim, MD, PhD', 'role': 'CONTACT', 'email': 'jhee1@snu.ac.kr', 'phone': '+82-10-2072-4839'}], 'overallOfficials': [{'name': 'Jung Hee Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Asan Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'Samsung Medical Center', 'class': 'OTHER'}, {'name': 'Inha University Hospital', 'class': 'OTHER'}, {'name': 'Chonnam National University Hospital', 'class': 'OTHER'}, {'name': 'Nowon Eulji Medical Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Jung Hee Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}