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

NCT06068101 | Completed

• 1 other identifier: Primary Aldosteronism + Cancer
• Study Type: observational
• Target: 274
• Locations: 1 country
• Sites: 1

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.

Conditions

Thyroid Cancer, Papillary; Primary Aldosteronism

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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.

Interventions

Secreening test for primary aldosteronism and Confirmatory Testing DIAGNOSTIC_TEST

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 papillary thyroid cancer (PTC) and EH (essential hypertension)

Eligibility Criteria

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

Study Population

In this cross-sectional case-control study, PA 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. 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. 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.

You may qualify if:

• All patients with PTC and EH regardless of hypertension severity

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

Ana Alice Wolf Maciel

São Paulo, 01246-000, Brazil

Location

MeSH Terms

Conditions

Thyroid Cancer, Papillary; Hyperaldosteronism

Condition Hierarchy (Ancestors)

Adenocarcinoma, Papillary; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Thyroid Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adrenocortical Hyperfunction; Adrenal Gland Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 15, 2023
• First Posted: October 5, 2023
• Study Start: March 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: August 1, 2023
• Last Updated: October 5, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)