Active — Not RecruitingNot Applicable

Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

Germany, Italy3,656 participantsStarted 2015-01-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Mortality

Timeframe: From date of primary diagnosis of the adrenal incidentaloma to the date of death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.

Trial details

NCT IDNCT04917757

SponsorWuerzburg University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2019-08-31

Results submitted2023-02-04

View on ClinicalTrials.gov More Adrenal Incidentaloma trials