Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas (NAPACA)

Wuerzburg University Hospital

Status: Active, not recruiting

Conditions: Adrenal Incidentaloma

Treatments: Diagnostic Test: 1mg Dexamethasone test

Study type: Observational

Funder types: Other

Identifiers

NCT04917757

NAPACA-Outcome

Details and patient eligibility

About

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.

Full description

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

Enrollment: 3,656 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design