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

September 13, 2024 updated by: Qifu Li

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

  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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400016
        • Recruiting
        • Qifu Li, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

In this study, about 100 patients with unilateral protonaldehydes undergoing total adrenal resection will be continuously enrolled in this research center from December 2023.

Unilateral Primary Aldosteronism underwent total Adrenalectomy were continuously included

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
unilateral primary aldosteronism group
The patient was diagnosed with unilateral primary aldosteronism and underwent total adrenal resection
Other: Tissue 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
Other Names:
  • Tissue specimens were stained by CYP11B2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks after surgery
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.
2 weeks after surgery
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
2 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks after surgery
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
2 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qifu Li

Investigators

  • Study Chair: Li Qifu, First Affiliated Hospital of Chongqing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

October 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 2, 2024

First Submitted That Met QC Criteria

September 13, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 13, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGC-UPA-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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