Clincosm LogoSign in Get a demo

Steroid Panel for One-step Diagnosis of Adrenal Diseases

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04948970
Collaborator
(none)
400
Enrollment
30.3
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Development of New Technology for One-step Diagnosis of Adrenal Diseases Based on Adrenal Hormone Panel
    Anticipated Study Start Date :
    Jun 21, 2021
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Diagnostic accuracy of multisteroid panel for differentiating adrenal diseases [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 Outcome Measures

    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]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Study Chair: Jung Hee Kim, M.D., Ph.D., Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT04948970
    Other Study ID Numbers:
    • 2105-008-1215
    First Posted:
    Jul 2, 2021
    Last Update Posted:
    Jul 2, 2021
    Last Verified:
    Jun 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Adrenal Gland Diseases

    Study Results

    No Results Posted as of Jul 2, 2021