NCT06229405

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 8,200 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: —

Summary

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.

Detailed 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: 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

• Adrenal Tumor
• Primary Aldosteronism
• Cushing Syndrome
• Pheochromocytoma
• Adrenal Cortical Carcinoma

Timeline

• Start date: 2022-05-10
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-01-29
• Last updated: 2024-03-04

Locations

1 site across 1 country: South Korea