Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04948970
Other study ID # 2105-008-1215
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT06050057 - Surgical Treatment of Adrenal Diseases- Laparoscopic vs. Robotic-assisted Adrenalectomy
Completed NCT01676025 - Comparison Between Posterior Retroperitoneoscopic Adrenalectomy and Laparoscopic Adrenalectomy N/A
Completed NCT04139447 - DAnalysis of the Distribution of Adrenal Steroids in a Control Population
Not yet recruiting NCT03535532 - Unilateral Laparoscopic Adrenalectomy for Resistant Hypertension in Patients With Adrenal Diseases N/A
Completed NCT02618694 - Efficacy and Safety of Posterior Retroperitoneoscopic Adrenalectomy: A Comparative Study N/A
Recruiting NCT05322265 - Complication in Laparoscopic Renal and Adrenal Surgery (CLARAS)