Steroid Panel for One-step Diagnosis of Adrenal Diseases

Development of New Technology for One-step Diagnosis of Adrenal Diseases Based on Adrenal Hormone Panel

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.

Study Overview

• Status: Completed
• Conditions: Adrenal Disease

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 Type: Observational
• Enrollment (Actual): 400

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study subjects will consist of patients who were treated for adrenal diseases such as adrenal incidentaloma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma at Seoul National University Hospital, and who agreed to participate in this study at Seoul National University Hospital and Seoul National University Bundang Hospital.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of multisteroid panel for differentiating adrenal diseases	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.	Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy of each steroid component for differentiating adrenal diseases	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.	Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Study Chair: Jung Hee Kim, M.D., Ph.D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: June 24, 2021
• First Posted (Actual): July 2, 2021

Study Record Updates

• Last Update Posted (Actual): January 23, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Adrenal Gland Diseases
• Other Study ID Numbers: 2105-008-1215

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No