Clinical trial NCT05927961: Spatial Proteomics Profiles of Aldosterone-producing Adenoma and Unilateral Hyperplasia
Official title: Spatial Proteomics Profiles of Adrenal Adenoma/Hyperplasia Leading to Primary Aldosterone
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Keywords: primary aldosteronism
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Screening for the biomarkers.
timeFrame: After APA/UAH resection/biopsy, usually within 6 months
Secondary outcomes:
measure: Incorporate biomarkers into the accurate and early diagnosis of PA.
timeFrame: 12 months
measure: Identifying the relationship between biomarkers and the prognosis of PA.
timeFrame: 12 months
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The Third Affiliated Hospital of the Third Military Medical University
Study officials:
affiliation: The third hospital affiliated to the Third Millitary Medical University
name: Yan Zhencheng, MD
role: PRINCIPAL_INVESTIGATOR
References: