Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06597630

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Primary Aldosteronism Adrenal Gland Diseases Adrenocortical Hyperfunction Endocrine System Diseases Hyperaldosteronism

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Qifu Li, PhD

Chongqing, Chongqing Municipality, 400016, China

Location status: Recruiting

Location contact

Li Qifu, PhD

CONTACT

[email protected]

18696676815 ext. +86

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Bilateral disease
  • Partial of no biochemical response in follow-up
  • partial adrenalectomy

Treatment and study plan

Tissue specimens were stained by histopathology of hematoxylin-eosin

Other

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

Other names: Tissue specimens were stained by CYP11B2

Primary outcomes

  1. Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions

    Time frame: 2 weeks after surgery

    Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining

  2. The proportion with genetic mutations

    Time frame: 2 weeks after surgery

    The adrenal tumor was diagnosed by gene sequencing as KCNJ5 mutation, ATP1A1 mutation, ATP2B3 mutation or CACNA1D mutation,etc.

  3. Analyze the Aldosterone level and renin level Characteristics

    Time frame: 2 weeks after surgery

    Aldosterone 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 outcomes

  1. Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions

    Time frame: 2 weeks after surgery

    Adrenal operative specimens were diagnosed as aldosterone-producing adenoma、aldosterone-producing nodule、aldosterone-producing micronodules、aldosterone-producing diffusehyperplasia according to HE and CYP11B2 staining

  2. Analyze the blood potassium and blood pressure Characteristics

    Time frame: 2 weeks after surgery

    Primary aldosterone has varying degrees of hypertension with or without hypokalemia

Study contacts

Contact information is provided by the study sponsor or research team.

Li Qifu

CONTACT

[email protected]

02389011552

Sponsors and collaborators

Lead sponsor

Qifu Li

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.