Clinical trial NCT06229405: Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data
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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adrenal Tumor
Primary Aldosteronism
Cushing Syndrome
Pheochromocytoma
Adrenal Cortical Carcinoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Asan Medical Center
name: Seoul National University Bundang Hospital
name: Samsung Medical Center
name: Inha University Hospital
name: Chonnam National University Hospital
name: Nowon Eulji Medical Center
First posted: 2024-01-29
Enrollment: 8200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with adrenal disorders

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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence rate of cardiovascular event
timeFrame: up to 20years
Secondary outcomes:
measure: Mortality rate
timeFrame: up to 20years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jung Hee Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: