Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data
NCT ID: NCT06229405
Last Updated: 2024-03-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
8200 participants
OBSERVATIONAL
2022-05-10
2024-12-31
Brief Summary
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Detailed Description
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1. Generating real-world healthcare data through prospective and retrospective registries specific to each adrenal disease.
2. Acquiring a common data model for adrenal diseases, applicable across both domestic and international multicenter settings.
3. Creating real-world data linked with hospital medical records and public data for each adrenal disease, utilizing anonymized information merging services.
4. 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.
Study Design:
Prospective and retrospective patient registries.
Study Population:
Patients with adrenal gland disorders, including primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion
Research Methods:
1. Securing prospective and retrospective registries of patients with adrenal diseases.
2. Obtaining a common data model for adrenal diseases.
3. Utilizing the secured registries and common data model for multicenter studies to generate clinical evidence for adrenal diseases.
4. Linking public and medical data with the secured registries to further research in generating clinical evidence for adrenal diseases.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Nonfunctioning adrenal adenoma
Incidentally detected adrenal mass without hormone production
No interventions assigned to this group
Mild autonomous cortisol secretion
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
No interventions assigned to this group
Adrenal Cushing syndrome
Adrenal diseases characterized by biochemical hypercortisolism accompanying with overt Cushingoid features.
No interventions assigned to this group
Primary aldosteronism
Adrenal diseases characterized by the excessive production of the hormone aldosterone and suppressed renin.
Diagnostic criteria are as the following:
1. Plasma aldosterone level of ≥6 ng/dL after a seated saline infusion test
2. Plasma aldosterone level of ≥13 ng/dL after a captopril challenge test.
No interventions assigned to this group
Pheochromocytoma and paraganglioma
Chromaffin-originated tumors in the adrenal gland and others, characterized by catecholamine excess
No interventions assigned to this group
Adrenal cortical carcinoma
Malignant tumors originated from the adrenal cortex, which was confirmed by biopsy or pathology results
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* patients who are 19 years or older
Exclusion Criteria
19 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Seoul National University Bundang Hospital
OTHER
Samsung Medical Center
OTHER
Inha University Hospital
OTHER
Chonnam National University Hospital
OTHER
Nowon Eulji Medical Center
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
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Jung Hee Kim
Associate professor
Principal Investigators
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Jung Hee Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2204-155-1320
Identifier Type: -
Identifier Source: org_study_id
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