Natural History of Benign Nonfunctioning Adrenal Tumors: 10 Year Follow-up Results
试验速览
- 阶段
- 不适用
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Natural History of NFAT - horomnal activity
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients hospitalized because of NFAI between 2005-2012 at the Department of Endocrinology, Diabetes and Metabolic Disease, University Medical Center Ljubljana, Ljubljana, Slovenia.
排除标准
- •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
结局指标
主要结局
Natural History of NFAT - horomnal activity
时间窗: 10 years
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.
Natural History of NFAT - growth
时间窗: 10 years
To determine the change in size of NFAI on the CT scan (mm).
Natural History of NFAT - BMI
时间窗: 10 years
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.
次要结局
未报告次要终点
研究者
Mojca Jensterle
Clinical Professor
University Medical Centre Ljubljana