Steroid Panel for One-step Diagnosis of Adrenal Diseases

NCT04948970 | Completed

• 1 other identifier: 2105-008-1215
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Adrenal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Diagnostic accuracy of each steroid component for differentiating adrenal diseases

  Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who are diagnosed with adrenal diseases

You may not qualify if:

• Taking medications that can affect steroid metabolism
• Major depression, chronic alcoholism
• Suspected cancer metastasis to adrenal glands
• Other acute stress conditions

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, Urine, Saliva, Hair

MeSH Terms

Conditions

Adrenal Gland Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Jung Hee Kim, M.D., Ph.D.

  Seoul National University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2021
• First Posted: July 2, 2021
• Study Start: June 21, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 23, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)