Clinical trial NCT04917757: Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas
Official title: Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas - Substudy of the ENSAT (European Network for the Study of Adrenal Tumor) Registry
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Adrenal Incidentaloma
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
Collaborators: name: European Network for the Study of Adrenal Tumors
First posted: 2021-06-08
Enrollment: 3656
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: patients with adrenal incidentaloma

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/)

Eligibility criteria: 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 outcomes:
measure: Mortality
timeFrame: 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:
measure: Cardiovascular Morbidity
timeFrame: 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.
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University Hospital Würzburg
city: Turin
country: Italy
facility: University Turin
Study officials:
affiliation: Wuerzburg University Hospital
name: Martin Fassnacht, MD
role: STUDY_CHAIR
References:
citation: 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.