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| Name | Class |
|---|---|
| University of Ljubljana, Faculty of Medicine | OTHER |
| University Rehabilitation Institute, Republic of Slovenia | OTHER |
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The data on long term natural history of benign nonfunctioning adrenal tumors (NFATs) are lacking. The aim is to identify clinical characteristics associated with tumor growth and progression to mild autonomous cortisol excess over time.
After being informed about the study, all patients with NFAT given written informed consent will underwent a control visit approximatly 10 years after initial visit at the outpateint clinic at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia. The included patients will be divided in three groups regarding the BMI as follows: BMI < 25 kg/m2, 25-30 kg/m2 and > 30 kg/m2. The investigators will assess clinical, and laboratory parameters and CT findings at the follow up visit and compere them to baseline characteristics.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMI < 25 kg/m2 | Those with NFAT and BMI < 25 kg/m2. |
| |
| BMI 25-30 kg/m2 | Those with NFAT and BMI 25-30 kg/m2. |
| |
| BMI > 30 kg/m2 | Those with NFAT and BMI > 30 kg/m2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT imaging | Radiation | CT of abdomen |
|
| Measure | Description | Time Frame |
|---|---|---|
| Natural History of NFAT - horomnal activity | To determine if and in how many pateints NFAI progressed to MACE. NFAI: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is < 50 nmol/l and no typical clinical signs of Cushing's syndrome are present. Pheochromocytoma and primary aldosteronism will be excluded. MACE: when cortisol after 1 mg overnight dexamethasone (ODST) suppression test is > 50 nmol/l. | 10 years |
| Natural History of NFAT - growth | To determine the change in size of NFAI on the CT scan (mm). | 10 years |
| Natural History of NFAT - BMI | To determine the change in BMI and its correlation with outcome 1 and 2. Weight and height will be combined to report BMI in kg/m^2. | 10 years |
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Inclusion Criteria:
- Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.
Exclusion Criteria:
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Adult patients with diagnosisi of NFAI, hospitalized between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mojca Jensterle, MD, PhD | Contact | 003861 522 50 50 | mojca.jensterlesever@kclj.si |
| Name | Affiliation | Role |
|---|---|---|
| Mojca Jensterle, MD, PhD | University Medical Center Ljubljana, Slovenia | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Internal Medicine, Faculty of Medicine, University of Ljubljana, Ljubljana, Slovenia | Recruiting | Ljubljana | 1000 | Slovenia |
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| ID | Term |
|---|---|
| C538238 | Adrenal incidentaloma |
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| ID | Term |
|---|---|
| D000097873 | Postmortem Imaging |
| ID | Term |
|---|---|
| D001344 | Autopsy |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003952 | Diagnostic Imaging |
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venous blood sample
| D008919 |
| Investigative Techniques |