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

Sponsor
Instituto do Cancer do Estado de São Paulo (Other)
Overall Status
Completed
CT.gov ID
NCT06068101
Collaborator
Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)
274
1
53
5.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Secreening test for primary aldosteronism and Confirmatory Testing

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
274 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Clinical and Genetic Investigation of the Association Between Primary Aldosteronism and Thyroid Cancer
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Dec 1, 2022
Actual Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patients with papillary thyroid cancer (PTC) and EH (essential hypertension)

Primary Aldosteronism was investigated in all patients with PTC and EH (n= 137), regardless of hypertension severity, under active surveillance at a cancer institute from 2019 to 2022.

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

Patients with EH (essential hypertension) previously investigated for PA (primary aldosteronism)

The control group included 137 (1:1) age,sex and body mass index (BMI) matched individuals from a retrospective cohort of EH previously investigated for PA from 2011 to 2022.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ana Alice Wolf Maciel São Paulo Brazil 01246-000

Sponsors and Collaborators

  • Instituto do Cancer do Estado de São Paulo
  • Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
ANA ALICE WOLF MACIEL, Principal Investigator, Instituto do Cancer do Estado de São Paulo
ClinicalTrials.gov Identifier:
NCT06068101
Other Study ID Numbers:
  • Primary Aldosteronism + Cancer
First Posted:
Oct 5, 2023
Last Update Posted:
Oct 5, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 5, 2023