Natural History of NFAI: 10 Year Follow-up Results

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results

Conditions
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Adrenal Incidentaloma

Intervention / Treatment
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* Radiation: CT imaging


Participation Criteria
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Eligibility Criteria
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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: age below 18 years relatives reported that patient died in the time since hospitalization patient did not want a follow up patient did not attend follow up appointment patient underwent adrenalectomy misdiagnosis / missing main information in hospitalization record

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BMI < 25 kg/m2<br>Those with NFAT and BMI < 25 kg/m2. | Radiation: CT imaging<br>* CT of abdomen<br>|
| BMI 25-30 kg/m2<br>Those with NFAT and BMI 25-30 kg/m2. | Radiation: CT imaging<br>* CT of abdomen<br>|
| BMI > 30 kg/m2<br>Those with NFAT and BMI > 30 kg/m2. | Radiation: CT imaging<br>* CT of abdomen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BMI, adrenal incidentaloma, NFAI, MACE, long term follow up, natural history