Status:
ACTIVE_NOT_RECRUITING
Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas
Lead Sponsor:
Wuerzburg University Hospital
Collaborating Sponsors:
European Network for the Study of Adrenal Tumors
Conditions:
Adrenal Incidentaloma
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
The NAPACA Outcome Study is part of the ENSAT Registry (https://registry.ensat.org/)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2025
Estimated Enrollment :
3656 Patients enrolled
Trial Details
Trial ID
NCT04917757
Start Date
January 1 2015
End Date
December 31 2025
Last Update
September 5 2025
Active Locations (2)
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1
University Hospital Würzburg
Würzburg, Germany, 97080
2
University Turin
Turin, Italy