A Prospective Cohort Study for Patients With Adrenal Diseases

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03474237
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Seoul National University Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jung Hee Kim, M.D
Principal Investigator Affiliation	Seoul National University Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Adrenal Adenoma, Cushing Syndrome, Pheochromocytoma, Adrenal Incidentaloma, Adrenocortical Carcinoma, Primary Hyperaldosteronism

Additional Details

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.

Arms & Interventions

Arms

: Non-functioning adrenal incidentaloma

patients who were diagnosed with non-functioning adrenal incidentaloma on computed tomography or magnetic resonance imaging

: Pheochromocytoma

patients who were diagnosed with pheochromocytoma biochemically or histologically

: Primary aldosteronism

patients who were diagnosed with primary aldosteronism by saline loading test

: Adrenal cushing syndrome

patients who were diagnosed with adrenal cushing syndrome by dexamethasone suppression test and 24 urine free cortisol test.

: Adrenocortical carcinoma

patients who were diagnosed with adrenocortical carcinoma by imaging study or histologic exam

Interventions

Other: - Hormone study and Imaging study

Blood (basal hormone and follow up hormone study) Imaging examination including computed tomography scan or magnetic resonance imaging

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Seoul National University Hospital, Seoul, Korea, Republic of

Status

Address

Seoul National University Hospital

Seoul, , 03080

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