Spatial Proteomics Profiles of Aldosterone-producing Adenoma and Unilateral Hyperplasia

NCT ID: NCT05927961

Last Updated: 2023-07-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-31
• Study Completion Date: 2024-05-25

Brief Summary

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.

Conditions

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

aldosterone-producing adenoma

Histopathology shows a clear boundary between adrenal adenoma and surrounding normal tissue.

histopathology

Intervention Type: DIAGNOSTIC_TEST

There is a clear boundary between adrenal adenoma and surrounding normal tissue. There is no clear boundary between adrenal hyperplasia and surrounding normal tissues.

unilateral hyperplasia

Histopathology shows no clear boundary between adrenal hyperplasia and surrounding normal tissues.

histopathology

Intervention Type: DIAGNOSTIC_TEST

There is a clear boundary between adrenal adenoma and surrounding normal tissue. There is no clear boundary between adrenal hyperplasia and surrounding normal tissues.

Interventions

histopathology

There is a clear boundary between adrenal adenoma and surrounding normal tissue. There is no clear boundary between adrenal hyperplasia and surrounding normal tissues.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Military Medical University

OTHER

Sponsor Role: lead

Responsible Party

Zhiming Zhu

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yan Zhencheng, MD

Role: PRINCIPAL_INVESTIGATOR

The third hospital affiliated to the Third Millitary Medical University

Locations

The Third Affiliated Hospital of the Third Military Medical University

Chongqing, , China

Countries

China

Central Contacts

Yan Zhencheng, MD

Role: CONTACT

zhenchengyan@sina.com

86-13983656682 ext. 86-02368757882

Facility Contacts

Zhencheng Yan, MD

Role: primary

zhenchengyan@sina.com

+86023729582

Other Identifiers

SPP of APA/UAH

Identifier Type: -

Identifier Source: org_study_id