Spatial Proteomics Profiles of Aldosterone-producing Adenoma and Unilateral Hyperplasia

NCT05927961 | Unknown

• 1 other identifier: SPP of APA/UAH
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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)

Keywords

primary aldosteronism

Outcome Measures

Primary Outcomes (1)

• Screening for the biomarkers.

  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.

  After APA/UAH resection/biopsy, usually within 6 months

Secondary Outcomes (2)

• Incorporate biomarkers into the accurate and early diagnosis of PA.

  12 months

• Identifying the relationship between biomarkers and the prognosis of PA.

  12 months

Study Arms (2)

aldosterone-producing adenoma

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

Diagnostic Test: histopathology

unilateral hyperplasia

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

Diagnostic Test: histopathology

Interventions

histopathology 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.

aldosterone-producing adenoma; unilateral hyperplasia

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

We'd like to collect the samples of adrenal from primary aldosterone patients due to aldosterone-producing adenoma and unilateral hyperplasia from August 2023 to May 2024.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Military Medical University: lead

Study Sites (1)

The Third Affiliated Hospital of the Third Military Medical University

Chongqing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples of adrenal collected from aldosterone-producing adenoma and unilateral hyperplasia by operation.

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Yan Zhencheng, MD

  The third hospital affiliated to the Third Millitary Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhencheng, MD

CONTACT

86-13983656682; zhenchengyan@sina.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 17, 2023
• First Posted: July 3, 2023
• Study Start: August 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: May 25, 2024
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (1)