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临床试验/NCT04948970
NCT04948970已完成不适用

Development of New Technology for One-step Diagnosis of Adrenal Diseases Based on Adrenal Hormone Panel

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2021年6月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Diagnostic accuracy of multisteroid panel for differentiating adrenal diseases

研究概览

简要总结

The aim of this study is to develop a one-step diagnostic method for adrenal diseases, Patients with adrenal diseases including non-functioning adrenal adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Using mass spectrometry analysis based on a multisteroid panel, serum, urine, saliva, and hair samples of the patients will be analyzed. The diagnostic yield of each and combination of steroids will be evaluated.

详细描述

Adrenal diseases consist of heterogenous diseases. To differentiate various adrenal diseases, multiple steps of diagnostic tests are needed. In this study, the investigators aimed to develop a one-step diagnostic method to differentiate various adrenal diseases using multisteroid panel.

About 400 patients with adrenal diseases including non-functioning adenoma, adrenal Cushing's syndrome, primary aldosteronism, and pheochromocytoma will be recruited. Serum, hair, saliva, and urine samples of the patients will be analyzed using mass spectrometry. Each and combination of multisteroid will be evaluated for diagnosing adrenal diseases.

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

入选标准

  • Patients who are diagnosed with adrenal diseases

排除标准

  • Taking medications that can affect steroid metabolism
  • Major depression, chronic alcoholism
  • Suspected cancer metastasis to adrenal glands
  • Other acute stress conditions

结局指标

主要结局

Diagnostic accuracy of multisteroid panel for differentiating adrenal diseases

时间窗: Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made

* Evaluate how accurately the developed multisteroid panel diagnoses adrenal disease by measuring sensitivity (%) and specificity (%) for diagnosis of Cushing's syndrome. * Evaluate how accurately the developed multisteroid panel diagnoses adrenal disease by measuring sensitivity (%) and specificity (%) for diagnosis of primary aldosteronism. * Evaluate how accurately the developed multisteroid panel diagnoses adrenal disease by measuring sensitivity (%) and specificity (%) for diagnosis of pheochromocytoma.

次要结局

  • Diagnostic accuracy of each steroid component for differentiating adrenal diseases(Within 1 year after subject recruitment when the final diagnosis of adrenal diseases are made)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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