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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Другое 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 CYP11

Первичные конечные точки

• Define the aldosterone-producing adenoma and aldosterone-producing nodule(classical)proportions [Срок оценки: 2 weeks after surgery]
• The proportion with genetic mutations [Срок оценки: 2 weeks after surgery]
• Analyze the Aldosterone level and renin level Characteristics [Срок оценки: 2 weeks after surgery]

Вторичные конечные точки (2)

• Define the ldosterone-producing micronodules and aldosterone-producing diffusehyperplasia(Nonclassical)proportions [Срок оценки: 2 weeks after surgery]
• Analyze the blood potassium and blood pressure Characteristics [Срок оценки: 2 weeks after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Qifu Li, PhD — Чунцин

Публикации

• Rossi GP, Sechi LA, Giacchetti G, Ronconi V, Strazzullo P, Funder JW. Primary aldosteronism: cardiovascular, renal and metabolic implications. Trends Endocrinol Metab. 2008 Apr;19(3):88-90. doi: 10.1016/j.tem.2008.01.006. Epub 2008 Mar 7. PMID 18314347
• Monticone S, D'Ascenzo F, Moretti C, Williams TA, Veglio F, Gaita F, Mulatero P. Cardiovascular events and target organ damage in primary aldosteronism compared with essential hypertension: a systematic review and meta-analysis. Lancet Diabetes Endocrinol. 2018 Jan;6(1):41-50. doi: 10.1016/S2213-8587(17)30319-4. Epub 2017 Nov 9. PMID 29129575
• Yang Y, Xiao M, Song Y, Tang Y, Luo T, Yang S, He W, Cheng Q, Ma L, Zhang Y, He Y, Cao Y, Yang J, Peng B, Hu J, Li Q. H-score of 11beta-hydroxylase and aldosterone synthase in the histopathological diagnosis of adrenocortical tumors. Endocrine. 2019 Sep;65(3):683-691. doi: 10.1007/s12020-019-02022-8. Epub 2019 Jul 22. PMID 31332713
• Yamazaki Y, Omata K, Tezuka Y, Ono Y, Morimoto R, Adachi Y, Ise K, Nakamura Y, Gomez-Sanchez CE, Shibahara Y, Kitamoto T, Nishikawa T, Ito S, Satoh F, Sasano H. Tumor Cell Subtypes Based on the Intracellular Hormonal Activity in KCNJ5-Mutated Aldosterone-Producing Adenoma. Hypertension. 2018 Sep;72(3):632-640. doi: 10.1161/HYPERTENSIONAHA.118.10907. PMID 30354756
• Sun N, Meyer LS, Feuchtinger A, Kunzke T, Knosel T, Reincke M, Walch A, Williams TA. Mass Spectrometry Imaging Establishes 2 Distinct Metabolic Phenotypes of Aldosterone-Producing Cell Clusters in Primary Aldosteronism. Hypertension. 2020 Mar;75(3):634-644. doi: 10.1161/HYPERTENSIONAHA.119.14041. Epub 2020 Jan 20. PMID 31957522
• Xu Z, Yang J, Hu J, Song Y, He W, Luo T, Cheng Q, Ma L, Luo R, Fuller PJ, Cai J, Li Q, Yang S; Chongqing Primary Aldosteronism Study (CONPASS) Group. Primary Aldosteronism in Patients in China With Recently Detected Hypertension. J Am Coll Cardiol. 2020 Apr 28;75(16):1913-1922. doi: 10.1016/j.jacc.2020.02.052. PMID 32327102
• Monticone S, Burrello J, Tizzani D, Bertello C, Viola A, Buffolo F, Gabetti L, Mengozzi G, Williams TA, Rabbia F, Veglio F, Mulatero P. Prevalence and Clinical Manifestations of Primary Aldosteronism Encountered in Primary Care Practice. J Am Coll Cardiol. 2017 Apr 11;69(14):1811-1820. doi: 10.1016/j.jacc.2017.01.052. PMID 28385310
• Funder JW. Primary aldosteronism as a public health issue. Lancet Diabetes Endocrinol. 2016 Dec;4(12):972-973. doi: 10.1016/S2213-8587(16)30272-8. No abstract available. PMID 27886747

Идентификаторы

NCT: NCT06597630 · PGC-UPA-2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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