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Spatial Proteomics Profiles of Aldosterone-producing Adenoma and Unilateral Hyperplasia

T

Third Military Medical University

Status

Not yet enrolling

Conditions

Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Primary Aldosteronism Due to Aldosterone Producing Adenoma

Treatments

Diagnostic Test: histopathology

Study type

Observational

Funder types

Other

Identifiers

NCT05927961
SPP of APA/UAH

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Trial design

30 participants in 2 patient groups

aldosterone-producing adenoma
Description:
Histopathology shows a clear boundary between adrenal adenoma and surrounding normal tissue.
Treatment:
Diagnostic Test: histopathology
unilateral hyperplasia
Description:
Histopathology shows no clear boundary between adrenal hyperplasia and surrounding normal tissues.
Treatment:
Diagnostic Test: histopathology

Trial contacts and locations

1

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Central trial contact

Yan Zhencheng, MD

Data sourced from clinicaltrials.gov

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