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临床试验/NCT05927961
NCT05927961尚未招募不适用

Spatial Proteomics Profiles of Adrenal Adenoma/Hyperplasia Leading to Primary Aldosterone

Third Military Medical University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Screening for the biomarkers.

研究概览

简要总结

Primary aldosteronism (PA) is a common cause of secondary hypertension, which is characterized by excessive aldosterone production by the adrenal gland. Excessive aldosterone can significantly increase the risk of cardiovascular disease and stroke. Patients with aldosterone-producing adenoma (APA) or unilateral hyperplasia (UAH) can be cured by unilateral adrenalectomy. The adrenal cortex is the outer part of the adrenal gland and is subdivided into three layers- the zona glomerulosa, the zona fasciculata, and the zona reticularis. And the outermost layer is the zona glomerulosa, and it's full of cells that make the hormone aldosterone. Although it has been investigated that the main cause of APA or UAH is the mutations of different calcium ion channels, including KCNJ5, CACNA1D, CLCN2 et al, it is still unknown whether there are any other changes of other proteins in different layers. Therefore, the investigators designed the study to characterize the proteomics profiles of adrenal adenoma/hyperplasia leading to primary aldosterone and identify biomarkers for early identification of PA by using spatial proteomics. The samples from adrenal adenoma or hyperplasia will be collected and analyzed by spatial proteomics in Hangzhou Jingjie Biotechnology Co., Ltd. The differentially expressed proteins in different layers will be screened out between APA and UAH, APA and its adjacent normal tissues, and UAH and its adjacent normal tissues, respectively. And KEGG analysis will be conducted to determine enriched pathway in these differentially expressed protein, respectively.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • According to the 2020 guidelines for primary aldosteronism, patients with positive primary aldosteronism confirmed test;
  • Patients with predominant unilateral aldosterone secretion at AVS; adrenal CT suggesting unilateral adrenal adenoma (> 0.8cm diameter) and no abnormalities in contralateral adrenal morphology.
  • Patients who agreed to do the adrenalectomy.

排除标准

  • adrenal CT suggests abnormal bilateral adrenal morphology or unilateral nodules.
  • glucocorticoids can treat aldosteronism (GRA) and familial aldosteronism.
  • other secondary hypertension: renal parenchymal hypertension, renal artery stenosis, Cushing syndrome, adrenal myeloid hyperplasia, aortic narrowing, obstructive sleep apnea hypoventilation syndrome.
  • any other unsuitable condition for surgery.
  • Patients who refused to perform adrenalectomy.

结局指标

主要结局

Screening for the biomarkers.

时间窗: After APA/UAH resection/biopsy, usually within 6 months

Histological validation of the CYP11B2 positive area in APA and UAH by immunohistochemical staining (IHC). Some specimens will be characterized more deeply with advanced spatial proteomics technologies to identify the biomarkers.

次要结局

  • Incorporate biomarkers into the accurate and early diagnosis of PA.(12 months)
  • Identifying the relationship between biomarkers and the prognosis of PA.(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhiming Zhu

professor

Third Military Medical University

研究点 (1)

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