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临床试验/NCT06068101
NCT06068101已完成不适用

Clinical and Genetic Investigation of the Association Between Primary Aldosteronism and Thyroid Cancer

Instituto do Cancer do Estado de São Paulo1 个研究点 分布在 1 个国家目标入组 274 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
274
试验地点
1
主要终点
PA prevalence in a transversal cohort of patients with PTC and EH

研究概览

简要总结

Aldosterone excess can cause oxidative stress leading to DNA damage in vitro and in vivo. Single case reports demonstrated a coincidence of primary aldosteronism (PA) with different malignancies. A higher prevalence of thyroid nodules and non-toxic multinodular goiter was described in patients with PA compared to those with essential hypertension (EH). A single study showed an association between PA and papillary thyroid cancer (PTC), but without a paired control group. Objective: To assess PA prevalence in a transversal cohort of patients with PTC and EH compared to a paired control group with HT.

详细描述

Primary aldosteronism (PA) is the most frequent cause of endocrine hypertension, with an estimated prevalence of 20% among individuals with resistant hypertension. PA is associated with an increased risk of malignancy, probably due to aldosterone effects in promoting cell proliferation. Recently, a high prevalence of PA was demonstrated in patients with essential hypertension (EH) and papillary thyroid cancer (PTC), similarly to the prevalence of PA among individuals with resistant EH. In addition, abnormalities in thyroid ultrasound (non-toxic multinodular goiter) are more common in PA patients when compared to controls. Despite of this initial evidence, the link between PA and PTC remains to be elucidated. Then, the aim of this study is to investigate the clinical and genetic aspects of the association between PA and PTC. The specific aims are: 1) To evaluate the prevalence of PA in a transversal cohort of patients with EH and PCT; 2) To investigate thyroid ultrasonography abnormalities in PA patients; 3) To perform exome sequencing (blood DNA) in patients with PA and PTC paired with tumor tissue; and 4) To conduct functional studies of the novel genetic variants identified by exome sequencing. To achieve this goal, the investigators will employ the following techniques: next-generation sequencing, bioinformatic analysis, real-time PCR and immunohistochemistry. In this project, the investigators expect to establish the prevalence of PA among patients with EH and PTC, and to identify new genetic targets involved in the association between PA in PTC.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with PTC and EH regardless of hypertension severity

排除标准

  • Patients who were using medications that secondarily increase blood pressure levels were excluded
  • Did not agree to participate

结局指标

主要结局

PA prevalence in a transversal cohort of patients with PTC and EH

时间窗: Through study completion, an average of 1,5 year

To assess PA prevalence in a transversal cohort of patients with PTC and EH compared to a paired control group with EH

次要结局

未报告次要终点

研究者

发起方
Instituto do Cancer do Estado de São Paulo
申办方类型
Other
责任方
Principal Investigator
主要研究者

ANA ALICE WOLF MACIEL

Principal Investigator

Instituto do Cancer do Estado de São Paulo

研究点 (1)

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