Adrenal TumorNCT06229405
Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data
An observational study of Adrenal Tumor and Primary Aldosteronism, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This research aims to establish clinical evidence for optimal treatment guidelines for adrenal diseases using real-world data. The approach involves building prospective and retrospective patient registries, which will be utilized to develop and conduct research on disease-specific protocols for adrenal disorders. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Adrenal Tumor, Primary Aldosteronism, Cushing Syndrome
- Type of treatment
- Injection or infusion
- How many people
- 8,200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 10 May 2022to 31 Dec 2024
- How long will I take part?
- 20 Years
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: patients with adrenal disorders
Who may be able to join
- patients with adrenal diseases such as adrenal cortical carcinoma, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal incidentaloma
- patients who are 19 years or older
Who cannot join
- patients younger than 19 years old
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Jung Hee Kim, M.D, jhkxingfu@gmail.com
About this study
Official title: Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data: An Initiative by the Korean Adrenal Disorder Study (KADS) Group
This research aims to establish clinical evidence for optimal treatment guidelines for adrenal diseases using real-world data. The approach involves building prospective and retrospective patient registries, which will be utilized to develop and conduct research on disease-specific protocols for adrenal disorders. The study targets patients with primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion. Registries for patients with adrenal diseases will be obtained from Seoul National University Hospital and Asan Medical Center, along with securing a common data model. The ultimate goal is to conduct research to generate clinical evidence for adrenal diseases using these resources.
Read the detailed description
The ultimate goal is to develop clinical evidence for unmet needs in adrenal gland diseases using real-world data, thereby contributing to the optimization of treatment guidelines. This involves:
- Generating real-world healthcare data through prospective and retrospective registries specific to each adrenal disease.
- Acquiring a common data model for adrenal diseases, applicable across both domestic and international multicenter settings.
- Creating real-world data linked with hospital medical records and public data for each adrenal disease, utilizing anonymized information merging services.
- Developing and conducting research based on prospective and retrospective registries, a common data model, and the utilization of public-medical data for different adrenal diseases.
Study Design:
Prospective and retrospective patient registries.
Study Population:
Patients with adrenal gland disorders, including primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion
Research Methods:
- Securing prospective and retrospective registries of patients with adrenal diseases.
- Obtaining a common data model for adrenal diseases.
- Utilizing the secured registries and common data model for multicenter studies to generate clinical evidence for adrenal diseases.
- Linking public and medical data with the secured registries to further research in generating clinical evidence for adrenal diseases.
- Conditions
- Adrenal Tumor, Primary Aldosteronism, Cushing Syndrome, Pheochromocytoma, Adrenal Cortical Carcinoma
- Medical subject headings
- Adrenal Gland Neoplasms, Hyperaldosteronism, Cushing Syndrome, Pheochromocytoma, Adrenocortical Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Nonfunctioning adrenal adenoma | Incidentally detected adrenal mass without hormone production | |
| Mild autonomous cortisol secretion | Adrenal tumors that do not meet the criteria for adrenal Cushing's syndrome but are not suppressed to below 1.8 µg/dL after the dexamethasone suppression test | |
| Adrenal Cushing syndrome | Adrenal diseases characterized by biochemical hypercortisolism accompanying with overt Cushingoid features. | |
| Primary aldosteronism | Adrenal diseases characterized by the excessive production of the hormone aldosterone and suppressed renin. Diagnostic criteria are as the following: 1. Plasma aldosterone level of ≥6 ng/dL after a seated saline infusion test 2. Plasma aldosterone level of ≥13 ng/dL after a captopril challenge test. | |
| Pheochromocytoma and paraganglioma | Chromaffin-originated tumors in the adrenal gland and others, characterized by catecholamine excess | |
| Adrenal cortical carcinoma | Malignant tumors originated from the adrenal cortex, which was confirmed by biopsy or pathology results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of cardiovascular event
Cardiovascular event
Measured: up to 20years
Secondary outcomes (1)
Mortality rate
Mortality
Measured: up to 20years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start10 May 2022
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal TumorStudies 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
- 8,200 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Seoul National University Bundang Hospital, Samsung Medical Center, Inha University Hospital, Chonnam National University Hospital, Nowon Eulji Medical Center
- Responsible party
- Principal investigator, Jung Hee Kim, Seoul National University Hospital
- Investigators
- Jung Hee Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06229405
- Sponsor's protocol ID
- 2204-155-1320
- Status last verified
- Feb 2024
- First submitted
- 5 Jan 2024
- Last updated
- 4 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Clinical Evidence for Optimal Management of Adrenal Diseases Based on Real-World Data: An Initiative by the Korean Adrenal Disorder Study (KADS) Group
- ClinicalTrials.gov ID
- NCT06229405
- Acronym / sponsor ID
- 2204-155-1320
- Conditions
- Adrenal Tumor, Primary Aldosteronism, Cushing Syndrome, Pheochromocytoma, Adrenal Cortical Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 8,200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Seoul National University Bundang Hospital, Samsung Medical Center, Inha University Hospital, Chonnam National University Hospital, Nowon Eulji Medical Center
- Study start
- 10 May 2022 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Jan 2024 (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.
This research aims to establish clinical evidence for optimal treatment guidelines for adrenal diseases using real-world data. The approach involves building prospective and retrospective patient registries, which will be utilized to develop and conduct research on disease-specific protocols for adrenal disorders. The study targets patients with primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion. Registries for patients with adrenal diseases will be obtained from Seoul National University Hospital and Asan Medical Center, along with securing a common data model. The ultimate goal is to conduct research to generate clinical evidence for adrenal diseases using these resources.
Detailed description
The ultimate goal is to develop clinical evidence for unmet needs in adrenal gland diseases using real-world data, thereby contributing to the optimization of treatment guidelines. This involves:
- Generating real-world healthcare data through prospective and retrospective registries specific to each adrenal disease.
- Acquiring a common data model for adrenal diseases, applicable across both domestic and international multicenter settings.
- Creating real-world data linked with hospital medical records and public data for each adrenal disease, utilizing anonymized information merging services.
- Developing and conducting research based on prospective and retrospective registries, a common data model, and the utilization of public-medical data for different adrenal diseases.
Study Design:
Prospective and retrospective patient registries.
Study Population:
Patients with adrenal gland disorders, including primary aldosteronism, pheochromocytoma, adrenal cancer, adrenal incidentalomas, and mild autonomous cortisol secretion
Research Methods:
- Securing prospective and retrospective registries of patients with adrenal diseases.
- Obtaining a common data model for adrenal diseases.
- Utilizing the secured registries and common data model for multicenter studies to generate clinical evidence for adrenal diseases.
- Linking public and medical data with the secured registries to further research in generating clinical evidence for adrenal diseases.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Nonfunctioning adrenal adenoma | – | –Incidentally detected adrenal mass without hormone production |
| Mild autonomous cortisol secretion | – | –Adrenal tumors that do not meet the criteria for adrenal Cushing's syndrome but are not suppressed to below 1.8 µg/dL after the dexamethasone suppression test |
| Adrenal Cushing syndrome | – | –Adrenal diseases characterized by biochemical hypercortisolism accompanying with overt Cushingoid features. |
| Primary aldosteronism | – | –Adrenal diseases characterized by the excessive production of the hormone aldosterone and suppressed renin. Diagnostic criteria are as the following: 1. Plasma aldosterone level of ≥6 ng/dL after a seated saline infusion test 2. Plasma aldosterone level of ≥13 ng/dL after a captopril challenge test. |
| Pheochromocytoma and paraganglioma | – | –Chromaffin-originated tumors in the adrenal gland and others, characterized by catecholamine excess |
| Adrenal cortical carcinoma | – | –Malignant tumors originated from the adrenal cortex, which was confirmed by biopsy or pathology results |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with adrenal disorders
Key inclusion criteria (2 listed)
- patients with adrenal diseases such as adrenal cortical carcinoma, Cushing's syndrome, primary aldosteronism, pheochromocytoma, adrenal incidentaloma
- patients who are 19 years or older
Key exclusion criteria (1 listed)
- patients younger than 19 years old
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
Incidence rate of cardiovascular event
Time frame: up to 20years
Cardiovascular event
1 secondary outcome
Mortality rate
Time frame: up to 20years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
- Individual participant dataSharing planned: Undecided
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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, MD, PhD 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 Tumor and Primary Aldosteronism, 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 1 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: status not confirmed, as of the sponsor's last update on 4 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Hee Kim, MD, PhD (+82-10-2072-4839, jhee1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of cardiovascular event (time frame: up to 20years). 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 4 Mar 2024.