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

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.

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Estimated): 8200

Contacts and Locations

• Study Contact: Name: Jung Hee Kim, MD, PhD; Phone Number: +82-10-2072-4839; Email: jhee1@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Jung Hee Kim, M.D; Email: jhkxingfu@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

patients with adrenal disorders

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Nonfunctioning adrenal adenoma; Incidentally detected adrenal mass without hormone production
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
Adrenal Cushing syndrome; Adrenal diseases characterized by biochemical hypercortisolism accompanying with overt Cushingoid features.
Primary aldosteronism; 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; Chromaffin-originated tumors in the adrenal gland and others, characterized by catecholamine excess
Adrenal cortical carcinoma; Malignant tumors originated from the adrenal cortex, which was confirmed by biopsy or pathology results

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of cardiovascular event	Cardiovascular event	up to 20years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality rate	Mortality	up to 20years

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Samsung Medical Center; Asan Medical Center; Chonnam National University Hospital; Seoul National University Bundang Hospital; Inha University Hospital; Nowon Eulji Medical Center
• Investigators: Principal Investigator: Jung Hee Kim, MD, PhD, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 5, 2024
• First Submitted That Met QC Criteria: January 19, 2024
• First Posted (Actual): January 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 4, 2024
• Last Update Submitted That Met QC Criteria: February 29, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Adrenocortical Hyperfunction; Adrenal Cortex Neoplasms; Adrenal Cortex Diseases; Paraganglioma; Hyperaldosteronism; Cushing Syndrome; Pheochromocytoma; Adrenocortical Carcinoma; Adrenal Gland Neoplasms; Adrenal Gland Diseases
• Other Study ID Numbers: 2204-155-1320

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No