Adrenal DiseaseNCT04948970
Steroid Panel for One-step Diagnosis of Adrenal Diseases
An observational study of Adrenal Disease, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adrenal Disease
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Jun 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients who are diagnosed with adrenal diseases
Who cannot join
- Taking medications that can affect steroid metabolism
- Major depression, chronic alcoholism
- Suspected cancer metastasis to adrenal glands
- Other acute stress conditions
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital
Seoul, Jongno-gu, 03080
About this study
Official title: Development of New Technology for One-step Diagnosis of Adrenal Diseases Based on Adrenal Hormone Panel
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.
Read the 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.
- Conditions
- Adrenal Disease
- Medical subject headings
- Adrenal Gland Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study start21 Jun 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jung Hee Kim, M.D., Ph.D., Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04948970
- Sponsor's protocol ID
- 2105-008-1215
- Status last verified
- Jun 2021
- First submitted
- 14 Jun 2021
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of New Technology for One-step Diagnosis of Adrenal Diseases Based on Adrenal Hormone Panel
- ClinicalTrials.gov ID
- NCT04948970
- Acronym / sponsor ID
- 2105-008-1215
- Conditions
- Adrenal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Jun 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients who are diagnosed with adrenal diseases
Key exclusion criteria (4 listed)
- Taking medications that can affect steroid metabolism
- Major depression, chronic alcoholism
- Suspected cancer metastasis to adrenal glands
- Other acute stress conditions
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jung Hee Kim, M.D., Ph.D. study chair
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2024; AzTrials last refreshed its copy on 7 Nov 2026.