Steroid Panel for One-step Diagnosis of Adrenal Diseases

Adrenal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04948970
• Other study ID #: 2105-008-1215
• Status: Completed
• Start date: June 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: June 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adrenal Disease
• Adrenal Gland Diseases

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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