Steroid Panel for One-step Diagnosis of Adrenal Diseases

Completed

• Conditions: Adrenal Disease

• Registration Number: NCT04948970
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The aim of this study is to develop a one-step diagnostic method for adrenal diseases, Patients with adrenal diseases including non-functioning adrenal adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Using mass spectrometry analysis based on a multisteroid panel, serum, urine, saliva, and hair samples of the patients will be analyzed. The diagnostic yield of each and combination of steroids will be evaluated.

Detailed Description

Adrenal diseases consist of heterogenous diseases. To differentiate various adrenal diseases, multiple steps of diagnostic tests are needed. In this study, the investigators aimed to develop a one-step diagnostic method to differentiate various adrenal diseases using multisteroid panel.

About 400 patients with adrenal diseases including non-functioning adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Serum, hair, saliva, and urine samples of the patients will be analyzed using mass spectrometry. Each and combination of multisteroid will be evaluated for diagnosing adrenal diseases.

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-14
• Study Start: 2021-06-21
• Study First Submitted QC: 2021-06-24
• Study First Posted: 2021-07-02
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-01-22
• Last Update Posted: 2024-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients who are diagnosed with adrenal diseases

Exclusion Criteria

• Taking medications that can affect steroid metabolism
• Major depression, chronic alcoholism
• Suspected cancer metastasis to adrenal glands
• Other acute stress conditions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of multisteroid panel for differentiating adrenal diseases	Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made	* Evaluate how accurately the developed multisteroid panel diagnoses adrenal disease by measuring sensitivity (%) and specificity (%) for diagnosis of Cushing's syndrome.; * Evaluate how accurately the developed multisteroid panel diagnoses adrenal disease by measuring sensitivity (%) and specificity (%) for diagnosis of primary aldosteronism.; * Evaluate how accurately the developed multisteroid panel diagnoses adrenal disease by measuring sensitivity (%) and specificity (%) for diagnosis of pheochromocytoma.

Secondary Outcome Measures

Name	Time	Method
Diagnostic accuracy of each steroid component for differentiating adrenal diseases	Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made	Evaluate how accurately each component of the steroid panel differentiate adrenal diseases.; * Sensitivity (%) and specificity (%) of each steroid measures for adrenal Cushing's syndrome will be calculated.; * Sensitivity (%) and specificity (%) of each steroid measures for primary aldosteronism will be calculated.; * Sensitivity (%) and specificity (%) of each steroid measures for pheochromocytoma will be calculated.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of