Adrenal Incidentaloma
Conditions
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/)
Interventions
DIAGNOSTIC_TEST1mg Dexamethasone test
For each patient a 1mg dexamethasone test has been performed.
Sponsors
European Network for the Study of Adrenal Tumors
Wuerzburg University Hospital
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism) |
Countries
Germany, Italy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Non-functioning Adenoma cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L | 2,089 |
| Adenoma With Possible Autonomous Cortisol Secretion cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L | 1,320 |
| Adenoma With Autonomous Cortisol Secretion cortisol values after an overnight 1 mg dexamethasone suppression test: \> 138 nmol/L | 247 |
| Total | 3,656 |
Baseline characteristics
| Characteristic | Non-functioning Adenoma | Adenoma With Possible Autonomous Cortisol Secretion | Adenoma With Autonomous Cortisol Secretion | Total |
|---|---|---|---|---|
| adenoma diameter | 20 mm | 26 mm | 29 mm | 22 mm |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 685 Participants | 594 Participants | 113 Participants | 1392 Participants |
| Age, Categorical Between 18 and 65 years | 1404 Participants | 726 Participants | 134 Participants | 2264 Participants |
| Age, Continuous | 60 years | 63 years | 63 years | 61 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 34 Participants | 28 Participants | 5 Participants | 67 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2011 Participants | 1271 Participants | 238 Participants | 3520 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 44 Participants | 21 Participants | 4 Participants | 69 Participants |
| Region of Enrollment Europe | 154 participants | 98 participants | 18 participants | 270 participants |
| Region of Enrollment United States | 1935 participants | 1222 participants | 229 participants | 3386 participants |
| Sex: Female, Male Female | 1321 Participants | 860 Participants | 169 Participants | 2350 Participants |
| Sex: Female, Male Male | 768 Participants | 460 Participants | 78 Participants | 1306 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 143 / 2,089 | 168 / 1,320 | 41 / 247 |
| other Total, other adverse events | 724 / 2,002 | 547 / 1,250 | 123 / 232 |
| serious Total, serious adverse events | 145 / 1,892 | 130 / 1,208 | 22 / 225 |
Outcome results
Primary
Mortality
death
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-functioning Adenoma | Mortality | 143 Participants |
| Adenoma With Possible Autonomous Cortisol Secretion | Mortality | 168 Participants |
| Adenoma With Autonomous Cortisol Secretion | Mortality | 41 Participants |
Secondary
Cardiovascular Morbidity
Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)
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.
Population: The number of analyzed patients is slightly smaller than the total cohort, because for some patients no data on cardiovascular outcome were available.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Non-functioning Adenoma | Cardiovascular Morbidity | 145 Participants |
| Adenoma With Possible Autonomous Cortisol Secretion | Cardiovascular Morbidity | 130 Participants |
| Adenoma With Autonomous Cortisol Secretion | Cardiovascular Morbidity | 22 Participants |