Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas (NAPACA)

June 7, 2021 updated by: Martin Fassnacht, Wuerzburg University Hospital

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

4374

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Würzburg, Germany, 97080
        • University Hospital Würzburg
  • Italy
      • Turin, Italy
        • University Turin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients with adrenal incidentaloma

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: From date of primary diagnosis of the adrenal incidentaloma until December 31, 2018
death
From date of primary diagnosis of the adrenal incidentaloma until December 31, 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular morbidity
Time Frame: From date of primary diagnosis of the adrenal incidentaloma until December 31, 2018
Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)
From date of primary diagnosis of the adrenal incidentaloma until December 31, 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuerzburg University Hospital

Collaborators

European Network for the Study of Adrenal Tumors

Investigators

  • Study Chair: Martin Fassnacht, MD, Wuerzburg University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2015

Primary Completion (Actual)

May 31, 2021

Study Completion (Anticipated)

December 31, 2021

Study Registration Dates

First Submitted

June 1, 2021

First Submitted That Met QC Criteria

June 1, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 7, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NAPACA-Outcome

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

not yet decided.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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