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Clinical Trials/NCT04917757
NCT04917757
Active, not recruiting
Not Applicable

Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas - Substudy of the ENSAT (European Network for the Study of Adrenal Tumor) Registry

Wuerzburg University Hospital2 sites in 2 countries3,656 target enrollmentStarted: January 1, 2015Last updated:
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ConditionsAdrenal Incidentaloma

Overview

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
3,656
Locations
2
Primary Endpoint
Mortality
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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 1-mg overnight dexamethasone test.

Detailed Description

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

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Mortality

Time Frame: 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

Secondary Outcomes

  • Cardiovascular Morbidity(From date of primary diagnosis of the adrenal incidentaloma to the date of the first CV event or death or last follow-up (data lock August 31, 2019). Median follow-up duration was 7.0 years.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Martin Fassnacht

Chair Dept. of Endocrinology and Diabetes

Wuerzburg University Hospital

Study Sites (2)

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