Adrenal IncidentalomaNAPACANCT04917757

Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

An observational study of Adrenal Incidentaloma, run by Wuerzburg University Hospital at 2 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Adrenal Incidentaloma
What is being tested?: 1mg Dexamethasone test
How many people: 3,656 participants
Where: 2 sitesin 2 countries
Study dates: 1 Jan 2015to 31 Dec 2025
How long will I take part?: 36 Months
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients with adrenal incidentaloma

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

Germany1 site

University Hospital Würzburg
Würzburg, 97080

Other trials in Germany

Italy1 site

University Turin
Turin

Other trials in Italy

About this study

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

Read the detailed description

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

Conditions: Adrenal Incidentaloma
Being tested: 1mg Dexamethasone test
Medical subject headings: Adrenal incidentaloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

What is being measured

The primary outcome is the main question the study is designed to answer.

Mortality
death
Measured: 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.

Secondary outcomes (1)

Cardiovascular Morbidity
Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201531 Dec 2025

First posted8 Jun 2021
Study start1 Jan 2015
Primary completion31 Aug 2019
Study completion31 Dec 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Adrenal IncidentalomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 3,656 participants (actual)
Target duration: 36 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04917757
Sponsor's protocol ID: NAPACA-Outcome
Acronym: NAPACA
Status last verified: Aug 2025
First submitted: 1 Jun 2021
Last updated: 5 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: not yet decided.

Publications

Deutschbein T, Reimondo G, Di Dalmazi G, Bancos I, Patrova J, Vassiliadi DA, Nekic AB, Debono M, Lardo P, Ceccato F, Petramala L, Prete A, Chiodini I, Ivovic M, Pazaitou-Panayiotou K, Alexandraki KI, Hanzu FA, Loli P, Yener S, Langton K, Spyroglou A, Kocjan T, Zacharieva S, Valdes N, Ambroziak U, Suzuki M, Detomas M, Puglisi S, Tucci L, Delivanis DA, Margaritopoulos D, Dusek T, Maggio R, Scaroni C, Concistre A, Ronchi CL, Altieri B, Mosconi C, Diamantopoulos A, Iniguez-Ariza NM, Vicennati V, Pia A, Kroiss M, Kaltsas G, Chrisoulidou A, Marina LV, Morelli V, Arlt W, Letizia C, Boscaro M, Stigliano A, Kastelan D, Tsagarakis S, Athimulam S, Pagotto U, Maeder U, Falhammar H, Newell-Price J, Terzolo M, Fassnacht M. Age-dependent and sex-dependent disparity in mortality in patients with adrenal incidentalomas and autonomous cortisol secretion: an international, retrospective, cohort study. Lancet Diabetes Endocrinol. 2022 Jul;10(7):499-508. doi: 10.1016/S2213-8587(22)00100-0. Epub 2022 May 6.
PubMed 35533704

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingObservational study
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Adrenal Gland Neoplasm, Hypertension
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
RecruitingObservational study
Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors
Pheochromocytoma, Cardiovascular Complication

All Adrenal Incidentaloma trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas - Substudy of the ENSAT (European Network for the Study of Adrenal Tumor) Registry
ClinicalTrials.gov ID: NCT04917757
Acronym / sponsor ID: NAPACA / NAPACA-Outcome
Conditions: Adrenal Incidentaloma
Study type: Observational
Recruitment status: Active, not recruiting
Enrolment: 3,656 participants (actual)
Lead sponsor: Wuerzburg University HospitalUniversity, hospital or other
Collaborators: European Network for the Study of Adrenal Tumors
Study start: 1 Jan 2015 (actual)
Primary completion: 31 Aug 2019 (actual)
Study completion: 31 Dec 2025 (estimated)
First posted: 8 Jun 2021 (actual)
Results: Posted 8 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Observational model: Cohort
Time perspective: Other
Target follow-up: 36 Months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients with adrenal incidentaloma

Key inclusion criteria (6 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
1mg Dexamethasone testFor each patient a 1mg dexamethasone test has been performed.	Diagnostic test	–

Primary outcome

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

1 secondary outcome

Cardiovascular Morbidity
Time frame: 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.

Results and safety

Results posted to the registry on 8 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-functioning Adenoma	2,089	2,089
Adenoma With Possible Autonomous Cortisol Secretion	1,320	1,320
Adenoma With Autonomous Cortisol Secretion	247	247

Primary outcome: 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.. Count of participants. Unit: Participants

Measure	Non-functioning Adenoma n = 2089	Adenoma With Possible Autonomous Cortisol Secretion n = 1320	Adenoma With Autonomous Cortisol Secretion n = 247
Value	143	168	41

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From the date of primary diagnosis of the adrenal incidentaloma until the date of death or last follow-up (data lock December 31, 2018). Median follow-up duration was 7.0 years.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-functioning Adenoma	145 of 1,892 (7.7%)	724 of 2,002 (36.2%)	143 of 2,089
Adenoma With Possible Autonomous Cortisol Secretion	130 of 1,208 (10.8%)	547 of 1,250 (43.8%)	168 of 1,320
Adenoma With Autonomous Cortisol Secretion	22 of 225 (9.8%)	123 of 232 (53%)	41 of 247

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35533704Deutschbein T, Reimondo G, Di Dalmazi G, Bancos I, Patrova J, Vassiliadi DA, Nekic AB, Debono M, Lardo P, Ceccato F, Petramala L, Prete A, Chiodini I, Ivovic M, Pazaitou-Panayiotou K, Alexandraki KI, Hanzu FA, Loli P, Yener S, Langton K, Spyroglou A, Kocjan T, Zacharieva S, Valdes N, Ambroziak U, Suzuki M, Detomas M, Puglisi S, Tucci L, Delivanis DA, Margaritopoulos D, Dusek T, Maggio R, Scaroni C, Concistre A, Ronchi CL, Altieri B, Mosconi C, Diamantopoulos A, Iniguez-Ariza NM, Vicennati V, Pia A, Kroiss M, Kaltsas G, Chrisoulidou A, Marina LV, Morelli V, Arlt W, Letizia C, Boscaro M, Stigliano A, Kastelan D, Tsagarakis S, Athimulam S, Pagotto U, Maeder U, Falhammar H, Newell-Price J, Terzolo M, Fassnacht M. Age-dependent and sex-dependent disparity in mortality in patients with adrenal incidentalomas and autonomous cortisol secretion: an international, retrospective, cohort study. Lancet Diabetes Endocrinol. 2022 Jul;10(7):499-508. doi: 10.1016/S2213-8587(22)00100-0. Epub 2022 May 6.
Individual participant dataSharing planned: Undecided. not yet decided.

Related trials for Adrenal Incidentaloma

RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingObservational study
Clinical and Molecular Characteristics of Primary Aldosteronism in Blacks
Adrenal Gland Neoplasm, Hypertension
RecruitingPhase 4
Isturisa Treatment in Mild Autonomous Cortisol Secretion( MACS)
Mild Autonomous Cortisol Secretion (MACS)
RecruitingObservational study
Cardiovascular Complications After Adrenalectomy for Pheochromocytoma and Non-secreting Tumors
Pheochromocytoma, Cardiovascular Complication

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Martin Fassnacht, MD study chair

Wuerzburg University Hospital

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Adrenal Incidentaloma, run by Wuerzburg University Hospital at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 5 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04917757, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2025.