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

Pheochromocytoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06229405
• Other study ID #: 2204-155-1320
• Status: Recruiting
• Start date: May 10, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Seoul National University Hospital
• Contact: Jung Hee Kim, MD, PhD
• Phone: +82-10-2072-4839
• Email: jhee1[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 8200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Cortical Carcinoma
• Adrenal Gland Diseases
• Adrenal Gland Neoplasms
• Adrenal Tumor
• Adrenocortical Carcinoma
• Cushing Syndrome
• Hyperaldosteronism
• Pheochromocytoma
• Primary Aldosteronism

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (7)

Lead Sponsor	Collaborator
Seoul National University Hospital	Asan Medical Center, Chonnam National University Hospital, Inha University Hospital, Nowon Eulji Medical Center, Samsung Medical Center, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence rate of cardiovascular event	Cardiovascular event	up to 20years
Secondary	Mortality rate	Mortality	up to 20years