Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas

NCT04917757 | Active Not Recruiting Results

• 1 other identifier: NAPACA-Outcome
• Study Type: observational
• Target: 3,656
• Locations: 2 countries
• Sites: 2

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.

Conditions

Adrenal Incidentaloma

Outcome Measures

Primary Outcomes (1)

• Mortality

  death

  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

  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.

Interventions

1mg Dexamethasone test DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with adrenal incidentaloma

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• European Network for the Study of Adrenal Tumors: collaborator

Study Sites (2)

University Hospital Würzburg

Würzburg, 97080, Germany

Location

University Turin

Turin, Italy

Location

Related Publications (1)

• 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.

  PMID: 35533704 RESULT

MeSH Terms

Conditions

Adrenal incidentaloma

Results Point of Contact

• Title: Prof Dr. Martin Fassnacht
• Organization: University Hospital Würzburg

fassnacht_m@ukw.de

4993120139021

Study Officials

• Martin Fassnacht, MD

  Wuerzburg University Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Dept. of Endocrinology and Diabetes

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 8, 2021
• Study Start: January 1, 2015
• Primary Completion: August 31, 2019
• Study Completion: December 31, 2025
• Last Updated: September 5, 2025
• Results First Posted: October 8, 2024

Record last verified: 2025-08

Locations

DE (1); IT (1)