NCT04917757进行中（未招募）不适用
Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas - Substudy of the ENSAT (European Network for the Study of Adrenal Tumor) Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3,656
- 试验地点
- 2
- 主要终点
- Mortality
研究概览
简要总结
The primary aim of the study is to assess mortality and cardiovascular events potentially linked to cortisol excess in patients with adrenal incidentalomas stratified by cortisol values following the 1-mg overnight dexamethasone test.
详细描述
The NAPACA Outcome Study is part of the ENSAT Registry (https://registry.ensat.org/)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •age ≥18 years
- •adrenal incidentaloma (≥ 1cm) detected by cross-sectional imaging between January 1, 1996 and December 31, 2015
- •imaging characteristics suggestive for an adrenal adenoma or excluded malignancy by follow-up imaging
- •availability of a 1 mg dexamethasone test result
- •follow-up data on living status and occurrence of cardiovascular events
- •follow-up duration of at least 36 months.
排除标准
- •proven pheochromocytoma, primary hyperaldosteronism or adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome
- •clinical features suggestive for overt Cushing's syndrome; urinary free cortisol (UFC) ≥ 2-fold higher than the upper limit of normal of the local assay
- •any active malignancy (including adrenocortical cancer) at the time of primary diagnosis
结局指标
主要结局
Mortality
时间窗: From date of primary diagnosis of the adrenal incidentaloma to the date of death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.
death
次要结局
- Cardiovascular Morbidity(From date of primary diagnosis of the adrenal incidentaloma to the date of the first CV event or death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.)
研究者
Martin Fassnacht
Chair Dept. of Endocrinology and Diabetes
Wuerzburg University Hospital
研究点 (2)
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