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

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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Unknown
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06229405
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Seoul National University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jung Hee Kim, MD, PhD
Principal Investigator Affiliation	Seoul National University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adrenal Tumor, Primary Aldosteronism, Cushing Syndrome, Pheochromocytoma, Adrenal Cortical Carcinoma

Additional Details

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.

Arms & Interventions

Arms

: 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

Interventions

Contact a Trial Team

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