Adrenal AdenomaNCT03474237
A Prospective Cohort Study for Patients With Adrenal Diseases
An observational study of Adrenal Adenoma and Cushing Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adrenal Adenoma, Cushing Syndrome, Pheochromocytoma
- What is being tested?
- Hormone study and Imaging study
- How many people
- 1,500 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Oct 2018to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: study population of this study is the patients who are newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma
Who may be able to join
- Adults, male or female aged 19 years or older
- newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma
Who cannot join
- previous or current history of adrenal diseases
- using oral or intravenous steroids
- history of major depressive disorder
- history of chronic alcoholics
- history of any cancer with suspicious adrenal metastasis
- those with acute illness (ex- patients with acute coronary syndrome within 4 weeks, acute febrile disease)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma.
Read the detailed description
The investigators will recruit 150 patients annually for 10 years (adrenal incidentaloma 100 patients, pheochromocytoma 15 patients, primary aldosteronism 25 patients, adrenal cushing syndrome 10 patients, adrenocortical carcinoma 2 patients) and perform hormonal, biochemical, imaging exam according to each disease's clinical guidelines. Based on this, the investigators will identify pathologic features, complications, and prognostic factors of each disease.
- Conditions
- Adrenal Adenoma, Cushing Syndrome, Pheochromocytoma, Adrenal Incidentaloma, Adrenocortical Carcinoma, Primary Hyperaldosteronism
- Being tested
- Hormone study and Imaging study
- Keywords
- algorithms, adrenal adenoma, cushing syndrome, pheochromocytoma, adrenal incidentaloma, adreocortical carcinoma, primary hyperaldosteronism
- Medical subject headings
- ACTH Syndrome, Ectopic, Cushing Syndrome, Pheochromocytoma, Adrenal incidentaloma, Adrenocortical Carcinoma, Hyperaldosteronism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormone study and Imaging studyOther
- Blood (basal hormone and follow up hormone study)
- Imaging examination including computed tomography scan or magnetic resonance imaging
| Study group | Role | What they receive |
|---|---|---|
| Non-functioning adrenal incidentaloma | patients who were diagnosed with non-functioning adrenal incidentaloma on computed tomography or magnetic resonance imaging Receives: Other: Hormone study and Imaging study | |
| Pheochromocytoma | patients who were diagnosed with pheochromocytoma biochemically or histologically Receives: Other: Hormone study and Imaging study | |
| Primary aldosteronism | patients who were diagnosed with primary aldosteronism by saline loading test Receives: Other: Hormone study and Imaging study | |
| Adrenal cushing syndrome | patients who were diagnosed with adrenal cushing syndrome by dexamethasone suppression test and 24 urine free cortisol test. Receives: Other: Hormone study and Imaging study | |
| Adrenocortical carcinoma | patients who were diagnosed with adrenocortical carcinoma by imaging study or histologic exam Receives: Other: Hormone study and Imaging study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in remission
Remission rate
Measured: Up to 10 years
Secondary outcomes (1)
Complication of adrenal disease
all complications including deaths
Measured: Up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start1 Oct 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal AdenomaStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jung Hee Kim, Seoul National University Hospital
- Investigators
- Jung Hee Kim, M.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474237
- Sponsor's protocol ID
- 1801-010-911
- Status last verified
- Mar 2020
- First submitted
- 10 Mar 2018
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study for Patients With Adrenal Diseases
- ClinicalTrials.gov ID
- NCT03474237
- Acronym / sponsor ID
- 1801-010-911
- Conditions
- Adrenal Adenoma, Cushing Syndrome, Pheochromocytoma, Adrenal Incidentaloma, Adrenocortical Carcinoma, Primary Hyperaldosteronism
- Keywords
- algorithms, adrenal adenoma, cushing syndrome, pheochromocytoma, adrenal incidentaloma, adreocortical carcinoma, primary hyperaldosteronism
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 Mar 2018 (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 purpose of this study is to investigate the pathologic features, complications, and prognostic factors of functioning adrenal adenoma and suggest follow-up algorithms for adrenal incidentaloma.
Detailed description
The investigators will recruit 150 patients annually for 10 years (adrenal incidentaloma 100 patients, pheochromocytoma 15 patients, primary aldosteronism 25 patients, adrenal cushing syndrome 10 patients, adrenocortical carcinoma 2 patients) and perform hormonal, biochemical, imaging exam according to each disease's clinical guidelines. Based on this, the investigators will identify pathologic features, complications, and prognostic factors of each disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Non-functioning adrenal incidentaloma | – | Other: Hormone study and Imaging studypatients who were diagnosed with non-functioning adrenal incidentaloma on computed tomography or magnetic resonance imaging |
| Pheochromocytoma | – | Other: Hormone study and Imaging studypatients who were diagnosed with pheochromocytoma biochemically or histologically |
| Primary aldosteronism | – | Other: Hormone study and Imaging studypatients who were diagnosed with primary aldosteronism by saline loading test |
| Adrenal cushing syndrome | – | Other: Hormone study and Imaging studypatients who were diagnosed with adrenal cushing syndrome by dexamethasone suppression test and 24 urine free cortisol test. |
| Adrenocortical carcinoma | – | Other: Hormone study and Imaging studypatients who were diagnosed with adrenocortical carcinoma by imaging study or histologic exam |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- study population of this study is the patients who are newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma
Key inclusion criteria (2 listed)
- Adults, male or female aged 19 years or older
- newly diagnosed with adrenal disease such as adrenal incidentaloma, pheochromocytoma, primary aldosteronism, adrenal cushing syndrome, adrenocortical carcinoma
Key exclusion criteria (6 listed)
- previous or current history of adrenal diseases
- using oral or intravenous steroids
- history of major depressive disorder
- history of chronic alcoholics
- history of any cancer with suspicious adrenal metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormone study and Imaging study1. Blood (basal hormone and follow up hormone study) 2. Imaging examination including computed tomography scan or magnetic resonance imaging | Other | Adrenal cushing syndrome, Adrenocortical carcinoma, Non-functioning adrenal incidentaloma, Pheochromocytoma, Primary aldosteronism |
Primary outcome
Number of participants in remission
Time frame: Up to 10 years
Remission rate
1 secondary outcome
Complication of adrenal disease
Time frame: Up to 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- 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.
Jung Hee Kim, M.D principal investigator
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 Adenoma and Cushing Syndrome, 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 2 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 18 Mar 2020. 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?
This study is still under way. Results are not available in the source record yet.
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?
Number of participants in remission (time frame: Up to 10 years). 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 18 Mar 2020.