Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

Adrenal Incidentaloma Clinical Trial

— NAPACA  

Official title:

Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas - Substudy of the ENSAT (European Network for the Study of Adrenal Tumor) Registry

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04917757
• Other study ID #: NAPACA-Outcome
• Status: Active, not recruiting
• Start date: January 1, 2015
• Est. completion date: December 31, 2021

Study information

• Verified date: June 2021
• Source: Wuerzburg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The primary aim of the study is to assess mortality and cardiovascular events potentially linked to cortisol excess in patients with adrenal incidentalomas stratified by cortisol values following the 1-mg overnight dexamethasone test.

Description:

The NAPACA Outcome Study is part of the ENSAT Registry (https://registry.ensat.org/)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4374
• Est. completion date: December 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• age =18 years

• adrenal incidentaloma (= 1cm) detected by cross-sectional imaging between January 1, 1996 and December 31, 2015

• imaging characteristics suggestive for an adrenal adenoma or excluded malignancy by follow-up imaging

• availability of a 1 mg dexamethasone test result

• follow-up data on living status and occurrence of cardiovascular events

• follow-up duration of at least 36 months.

Exclusion Criteria:

• proven pheochromocytoma, primary hyperaldosteronism or adrenocorticotropic hormone (ACTH)-dependent Cushing's syndrome

• clinical features suggestive for overt Cushing's syndrome; urinary free cortisol (UFC) = 2-fold higher than the upper limit of normal of the local assay

• any active malignancy (including adrenocortical cancer) at the time of primary diagnosis

Related Conditions & MeSH terms

• Adrenal Gland Neoplasms
• Adrenal Incidentaloma
• Adrenocortical Adenoma

Intervention

Diagnostic Test:
• 1mg Dexamethasone test
For each patient a 1mg dexamethasone test has been performed.

Locations

Country	Name	City	State
Germany	University Hospital Würzburg	Würzburg
Italy	University Turin	Turin

Sponsors (2)

Lead Sponsor	Collaborator
Wuerzburg University Hospital	European Network for the Study of Adrenal Tumors

Countries where clinical trial is conducted

Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	death	From date of primary diagnosis of the adrenal incidentaloma until December 31, 2018
Secondary	Cardiovascular morbidity	Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)	From date of primary diagnosis of the adrenal incidentaloma until December 31, 2018