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Trial Title:
Spatial Proteomics Profiles of Aldosterone-producing Adenoma and Unilateral Hyperplasia
NCT ID:
NCT05927961
Condition:
Primary Aldosteronism Due to Aldosterone Producing Adenoma
Primary Aldosteronism Due to Adrenal Hyperplasia (Bilateral)
Conditions: Official terms:
Adenoma
Adrenocortical Adenoma
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Hyperaldosteronism
Hyperplasia
Conditions: Keywords:
primary aldosteronism
Study type:
Observational
Overall status:
Not yet recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
histopathology
Description:
There is a clear boundary between adrenal adenoma and surrounding normal tissue. There is
no clear boundary between adrenal hyperplasia and surrounding normal tissues.
Arm group label:
aldosterone-producing adenoma
Arm group label:
unilateral hyperplasia
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Third Affiliated Hospital of the Third Military Medical University
Address:
City:
Chongqing
Country:
China
Contact:
Last name:
Zhencheng Yan, MD
Phone:
+86023729582
Email:
zhenchengyan@sina.com
Start date:
August 2023
Completion date:
May 25, 2024
Lead sponsor:
Agency:
Third Military Medical University
Agency class:
Other
Source:
Third Military Medical University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05927961
