Clinical Trials in Italy / NCT04917757
Active, not recruiting
Observational
Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas
NCT04917757 · tracked via the Priya Life Science Italy tracker
Condition(s) studied
Adrenal Incidentaloma
Investigational drug(s) / intervention(s)
1mg Dexamethasone test
1mg Dexamethasone test: For each patient a 1mg dexamethasone test has been performed.
Study 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.
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
Primary outcome measure(s)
- Mortality — 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.
death
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| University Hospital Würzburg | Würzburg | Germany | |
| University Turin | Turin | Italy |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04917757 on ClinicalTrials.gov ↗ ← All trials in Italy