Adrenal Disease Clinical Trial
Official title:
Development of New Technology for One-step Diagnosis of Adrenal Diseases Based on Adrenal Hormone Panel
Verified date | June 2021 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Hospital | Seoul | Jongno-gu |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
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 |
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