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

Primary Aldosteronism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06068101
• Other study ID #: Primary Aldosteronism + Cancer
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: August 1, 2023

Study information

• Verified date: October 2023
• Source: Instituto do Cancer do Estado de São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 274
• Est. completion date: August 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with PTC and EH regardless of hypertension severity

Exclusion Criteria:

• Patients who were using medications that secondarily increase blood pressure levels were excluded

• Did not agree to participate

Related Conditions & MeSH terms

• Hyperaldosteronism
• Primary Aldosteronism
• Thyroid Cancer, Papillary
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Diagnostic Test:
• Secreening test for primary aldosteronism and Confirmatory Testing
Serum aldosterone and plasma direct renin concentrations were measured by a chemiluminescent immunoassay. A positive PA screening was defined by aldosterone > or = 10 ng/dL and aldosterone to renin ratio > or = 2 ng/dL/uUI/mL

Locations

Country	Name	City	State
Brazil	Ana Alice Wolf Maciel	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Instituto do Cancer do Estado de São Paulo	Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PA prevalence in a transversal cohort of patients with PTC and EH	To assess PA prevalence in a transversal cohort of patients with PTC and EH compared to a paired control group with EH	Through study completion, an average of 1,5 year