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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04948970
Enrollment
400
Registered
2021-07-02
Start date
2021-06-21
Completion date
2023-12-31
Last updated
2024-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Disease

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.

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of multisteroid panel for differentiating adrenal diseasesWithin 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

MeasureTime frameDescription
Diagnostic accuracy of each steroid component for differentiating adrenal diseasesWithin 1 year after subject recruitment when the final diagnosis of adrenal diseases are madeEvaluate 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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026