Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data

Seoul National University

Status: Enrolling

Conditions: Adrenal Cortical Carcinoma; Adrenal Tumor; Primary Aldosteronism; Cushing Syndrome; Pheochromocytoma

Study type: Observational

Funder types: Other

Identifiers

NCT06229405

2204-155-1320

Details and patient eligibility

About

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.

Full description

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:

Generating real-world healthcare data through prospective and retrospective registries specific to each adrenal disease. Acquiring a common data model for adrenal diseases, applicable across both domestic and international multicenter settings. Creating real-world data linked with hospital medical records and public data for each adrenal disease, utilizing anonymized information merging services. 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:

Securing prospective and retrospective registries of patients with adrenal diseases. Obtaining a common data model for adrenal diseases. Utilizing the secured registries and common data model for multicenter studies to generate clinical evidence for adrenal diseases. Linking public and medical data with the secured registries to further research in generating clinical evidence for adrenal diseases.

Enrollment: 8,200 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients with adrenal diseases such as adrenal cortical carcinoma, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal incidentaloma
• patients who are 19 years or older

Exclusion criteria

• patients younger than 19 years old

Trial design

8,200 participants in 6 patient groups

Nonfunctioning adrenal adenoma

Description:

Incidentally detected adrenal mass without hormone production

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

Adrenal Cushing syndrome

Description:

Adrenal diseases characterized by biochemical hypercortisolism accompanying with overt Cushingoid features.

Primary aldosteronism

Description:

Adrenal diseases characterized by the excessive production of the hormone aldosterone and suppressed renin. Diagnostic criteria are as the following: Plasma aldosterone level of ≥6 ng/dL after a seated saline infusion test Plasma aldosterone level of ≥13 ng/dL after a captopril challenge test.

Pheochromocytoma and paraganglioma

Description:

Chromaffin-originated tumors in the adrenal gland and others, characterized by catecholamine excess

Adrenal cortical carcinoma

Description:

Malignant tumors originated from the adrenal cortex, which was confirmed by biopsy or pathology results