Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

Study Results

Results available

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

3656 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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

Conditions

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Adrenal Incidentaloma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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1mg Dexamethasone test

For each patient a 1mg dexamethasone test has been performed.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No