Steroid Panel for One-step Diagnosis of Adrenal Diseases

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.

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Key information

Conditions

Adrenal Disease Adrenal Gland Diseases Endocrine System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Diagnostic accuracy of multisteroid panel for differentiating adrenal diseases

Time frame: 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 outcomes

Diagnostic accuracy of each steroid component for differentiating adrenal diseases

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Jul 2, 2021
Registry last updated: Jan 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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