A Prospective Cohort Study for Patients With Adrenal Diseases

• Conditions: Pheochromocytoma; Adrenal Incidentaloma; Adrenal Adenoma; Cushing Syndrome; Adrenocortical Carcinoma; Primary Hyperaldosteronism
• Interventions: Other: Hormone study and Imaging study

• Registration Number: NCT03474237
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma.

Detailed Description

The investigators will recruit 150 patients annually for 10 years (adrenal incidentaloma 100 patients, pheochromocytoma 15 patients, primary aldosteronism 25 patients, adrenal cushing syndrome 10 patients, adrenocortical carcinoma 2 patients) and perform hormonal, biochemical, imaging exam according to each disease's clinical guidelines. Based on this, the investigators will identify pathologic features, complications, and prognostic factors of each disease.

Study Timeline

• Study First Submitted: 2018-03-10
• Study First Submitted QC: 2018-03-15
• Study First Posted: 2018-03-22
• Study Start: 2018-10-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• Adults, male or female aged 19 years or older
• newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma

Exclusion Criteria

• previous or current history of adrenal diseases
• using oral or intravenous steroids
• history of major depressive disorder
• history of chronic alcoholics
• history of any cancer with suspicious adrenal metastasis
• those with acute illness (ex- patients with acute coronary syndrome within 4 weeks, acute febrile disease)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pheochromocytoma	Hormone study and Imaging study	patients who were diagnosed with pheochromocytoma biochemically or histologically
Primary aldosteronism	Hormone study and Imaging study	patients who were diagnosed with primary aldosteronism by saline loading test
Adrenocortical carcinoma	Hormone study and Imaging study	patients who were diagnosed with adrenocortical carcinoma by imaging study or histologic exam
Adrenal cushing syndrome	Hormone study and Imaging study	patients who were diagnosed with adrenal cushing syndrome by dexamethasone suppression test and 24 urine free cortisol test.
Non-functioning adrenal incidentaloma	Hormone study and Imaging study	patients who were diagnosed with non-functioning adrenal incidentaloma on computed tomography or magnetic resonance imaging

Primary Outcome Measures

Name	Time	Method
Number of participants in remission	Up to 10 years	Remission rate

Secondary Outcome Measures

Name	Time	Method
Complication of adrenal disease	Up to 10 years	all complications including deaths

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of