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Pathological Type,Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism

Pathological Type,Gene Mutation and Clinical Characteristics of Unilateral Primary Aldosteronism,A Prospective Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06597630
Enrollment
100
Registered
2024-09-19
Start date
2023-12-01
Completion date
2024-12-31
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Aldosteronism

Keywords

Pathological type, Gene mutation

Brief summary

1. Aim to investigate the pathological feature of UPA in Asians 2. To clarify the relationship between pathology, clinical phenotype, genetic mutation and surgical outcome of UPA in Asians. 3. To explore a new pathological type of unilateral primary aldosterone

Detailed description

The multi-center expert team led by Tracy Ann Williams formulated the International Consensus on the Pathological Diagnosis of Unilateral aldehyde disease, which standardized the pathological classification of unilateral PA. The previous retrospective study of the research group found that the pathologic types of unilateral primary aldosteronoma were mainly classical, and aldosteronoma was the most common. There was no significant difference in clinical features and postoperative biochemical remission rate between patients with classic and non-classic, but the clinical prognosis of the latter group was worse than that of the classical group. However, the study was retrospective and there may be inclusion bias. The pathologic distribution and clinical features of unilateral aldehyde disease are not completely clear and need to be discussed in prospective studies.Therefore,this study aims to determine the composition ratio of different pathological types in patients with unilateral procaldosis enrolled in our center. Gene mutation of different pathological types, the relationship between pathology and clinical phenotype, gene mutation, etc.

Interventions

OTHERTissue specimens were stained by histopathology of hematoxylin-eosin

Whole slide images were created by scanning the complete histologic slide to produce high-resolution digital files of the histopathology of hematoxylin-eosin and CYP11B2 immunostained sections.Tissue sections of all blocks from each resected adrenal were evaluated by hematoxylin and eosin and CYP11B2 immunostaining and adrenal specimens were categorized as classical or nonclassical histopathologic findings of unilateral PA according to the HISTALDO consensus; Genotyping was performed using CYP11B2 (aldosterone synthase)-guided sequencing

Sponsors

Qifu Li
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. No gender limitation; 2. Age 18-80 years old; 3. The patient was diagnosed with UPA and underwent total adrenal resection.

Exclusion criteria

1. Bilateral disease 2. Partial of no biochemical response in follow-up 3. partial adrenalectomy

Design outcomes

Primary

MeasureTime frameDescription
The proportion with genetic mutations2 weeks after surgeryThe adrenal tumor was diagnosed by gene sequencing as KCNJ5 mutation, ATP1A1 mutation, ATP2B3 mutation or CACNA1D mutation,etc.
Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions2 weeks after surgeryAdrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
Analyze the Aldosterone level and renin level Characteristics2 weeks after surgeryAldosterone level(pg/ml), renin level(uIU/ml), blood potassium(mmol/L) and blood pressure are the main clinical indicators of primary aldosteronism(Aldosterone level divided by renin level to obtain ARR, ARR greater than 20 consider whether aldosterone autonomic secretion),different pathological types of aldosteronomas were measured to analyze whether there were differences in clinical characteristics of adrenal tumors of different pathological types

Secondary

MeasureTime frameDescription
Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions2 weeks after surgeryAdrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining
Analyze the blood potassium and blood pressure Characteristics2 weeks after surgeryPrimary aldosterone has varying degrees of hypertension with or without hypokalemia

Countries

China

Contacts

Primary ContactLi Qifu
liqifu@yeah.net02389011552

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026