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

NCT06229405 | Recruiting

• 1 other identifier: 2204-155-1320
• Study Type: observational
• Target: 8,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Tumor; Primary Aldosteronism; Cushing Syndrome; Pheochromocytoma; Adrenal Cortical Carcinoma

Outcome Measures

Primary Outcomes (1)

• Incidence rate of cardiovascular event

  Cardiovascular event

  up to 20years

Secondary Outcomes (1)

• Mortality rate

  up to 20years

Study Arms (6)

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: 1. Plasma aldosterone level of ≥6 ng/dL after a seated saline infusion test 2. 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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with adrenal disorders

You may qualify if:

• patients with adrenal diseases such as adrenal cortical carcinoma, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal incidentaloma
• patients who are 19 years or older

You may not qualify if:

• patients younger than 19 years old

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Asan Medical Center: collaborator
• Seoul National University Bundang Hospital: collaborator
• Samsung Medical Center: collaborator
• Inha University Hospital: collaborator
• Chonnam National University Hospital: collaborator
• Nowon Eulji Medical Center: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum/Buffy coat to discover prognostic biomarkers and genetic background

MeSH Terms

Conditions

Adrenal Gland Neoplasms; Hyperaldosteronism; Cushing Syndrome; Pheochromocytoma; Adrenocortical Carcinoma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Adrenal Gland Diseases; Endocrine System Diseases; Adrenocortical Hyperfunction; Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Adrenal Cortex Neoplasms; Adrenal Cortex Diseases

Study Officials

• Jung Hee Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Hee Kim, MD, PhD

CONTACT

+82-10-2072-4839; jhee1@snu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 5, 2024
• First Posted: January 29, 2024
• Study Start: May 10, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 4, 2024

Record last verified: 2024-02

Locations

KR (1)