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

NCT06597630 | Recruiting

• 1 other identifier: PGC-UPA-2024
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Aldosteronism

Keywords

Pathological type; Gene mutation

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  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 Outcomes (2)

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

  2 weeks after surgery

• Analyze the blood potassium and blood pressure Characteristics

  2 weeks after surgery

Study Arms (1)

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

Interventions

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

Also known as: Tissue specimens were stained by CYP11B2

unilateral primary aldosteronism group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Qifu Li: lead

Study Sites (1)

Qifu Li, PhD

Chongqing, Chongqing Municipality, 400016, China

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Mete O, Asa SL, Giordano TJ, Papotti M, Sasano H, Volante M. Immunohistochemical Biomarkers of Adrenal Cortical Neoplasms. Endocr Pathol. 2018 Jun;29(2):137-149. doi: 10.1007/s12022-018-9525-8.

  PMID: 29542002 RESULT

• Nishimoto K, Koga M, Seki T, Oki K, Gomez-Sanchez EP, Gomez-Sanchez CE, Naruse M, Sakaguchi T, Morita S, Kosaka T, Oya M, Ogishima T, Yasuda M, Suematsu M, Kabe Y, Omura M, Nishikawa T, Mukai K. Immunohistochemistry of aldosterone synthase leads the way to the pathogenesis of primary aldosteronism. Mol Cell Endocrinol. 2017 Feb 5;441:124-133. doi: 10.1016/j.mce.2016.10.014. Epub 2016 Oct 14.

  PMID: 27751767 RESULT

• Gomez-Sanchez CE, Kuppusamy M, Reincke M, Williams TA. Disordered CYP11B2 Expression in Primary Aldosteronism. Horm Metab Res. 2017 Dec;49(12):957-962. doi: 10.1055/s-0043-122238. Epub 2017 Dec 4.

  PMID: 29202495 RESULT

• Nishimoto K, Nakagawa K, Li D, Kosaka T, Oya M, Mikami S, Shibata H, Itoh H, Mitani F, Yamazaki T, Ogishima T, Suematsu M, Mukai K. Adrenocortical zonation in humans under normal and pathological conditions. J Clin Endocrinol Metab. 2010 May;95(5):2296-305. doi: 10.1210/jc.2009-2010. Epub 2010 Mar 3.

  PMID: 20200334 RESULT

• Williams TA, Gomez-Sanchez CE, Rainey WE, Giordano TJ, Lam AK, Marker A, Mete O, Yamazaki Y, Zerbini MCN, Beuschlein F, Satoh F, Burrello J, Schneider H, Lenders JWM, Mulatero P, Castellano I, Knosel T, Papotti M, Saeger W, Sasano H, Reincke M. International Histopathology Consensus for Unilateral Primary Aldosteronism. J Clin Endocrinol Metab. 2021 Jan 1;106(1):42-54. doi: 10.1210/clinem/dgaa484.

  PMID: 32717746 RESULT

• Monticone S, Castellano I, Versace K, Lucatello B, Veglio F, Gomez-Sanchez CE, Williams TA, Mulatero P. Immunohistochemical, genetic and clinical characterization of sporadic aldosterone-producing adenomas. Mol Cell Endocrinol. 2015 Aug 15;411:146-54. doi: 10.1016/j.mce.2015.04.022. Epub 2015 May 6.

  PMID: 25958045 RESULT

• Williams TA, Lenders JWM, Mulatero P, Burrello J, Rottenkolber M, Adolf C, Satoh F, Amar L, Quinkler M, Deinum J, Beuschlein F, Kitamoto KK, Pham U, Morimoto R, Umakoshi H, Prejbisz A, Kocjan T, Naruse M, Stowasser M, Nishikawa T, Young WF Jr, Gomez-Sanchez CE, Funder JW, Reincke M; Primary Aldosteronism Surgery Outcome (PASO) investigators. Outcomes after adrenalectomy for unilateral primary aldosteronism: an international consensus on outcome measures and analysis of remission rates in an international cohort. Lancet Diabetes Endocrinol. 2017 Sep;5(9):689-699. doi: 10.1016/S2213-8587(17)30135-3. Epub 2017 May 30.

  PMID: 28576687 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Adrenal nodule tissue specimen

MeSH Terms

Conditions

Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Officials

• Li Qifu

  First Affiliated Hospital of Chongqing Medical University

  STUDY CHAIR

Central Study Contacts

Li Qifu

CONTACT

02389011552; liqifu@yeah.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Primary investigator

Study Record Dates

• First Submitted: September 2, 2024
• First Posted: September 19, 2024
• Study Start: December 1, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)