Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229405
Status:
RECRUITING
Last Update Posted:
2024-03-04
First Post:
2024-01-05
Brief Title:
Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data
Sponsor:
Seoul National University Hospital
Organization:
Seoul National University Hospital
Study Overview
Official Title:
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:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None