Trial Outcomes & Findings for Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas (NCT NCT04917757)
NCT ID: NCT04917757
Last Updated: 2025-09-05
Results Overview
death
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
3656 participants
Primary outcome 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.
Results posted on
2025-09-05
Participant Flow
Participant milestones
| Measure |
Non-functioning Adenoma
cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L
|
Adenoma With Possible Autonomous Cortisol Secretion
cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L
|
Adenoma With Autonomous Cortisol Secretion
cortisol values after an overnight 1 mg dexamethasone suppression test: \> 138 nmol/L
|
|---|---|---|---|
|
Overall Study
STARTED
|
2089
|
1320
|
247
|
|
Overall Study
COMPLETED
|
2089
|
1320
|
247
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Outcome of Autonomous Cortisol Secretion in Adrenal Incidentalomas
Baseline characteristics by cohort
| Measure |
Adenoma With Possible Autonomous Cortisol Secretion
n=1320 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L
|
Adenoma With Autonomous Cortisol Secretion
n=247 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test: \> 138 nmol/L
|
Total
n=3656 Participants
Total of all reporting groups
|
Non-functioning Adenoma
n=2089 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
726 Participants
n=107 Participants
|
134 Participants
n=206 Participants
|
2264 Participants
n=7 Participants
|
1404 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
594 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
1392 Participants
n=7 Participants
|
685 Participants
n=99 Participants
|
|
Age, Continuous
|
63 years
n=107 Participants
|
63 years
n=206 Participants
|
61 years
n=7 Participants
|
60 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
860 Participants
n=107 Participants
|
169 Participants
n=206 Participants
|
2350 Participants
n=7 Participants
|
1321 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
460 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
1306 Participants
n=7 Participants
|
768 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
28 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
67 Participants
n=7 Participants
|
34 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1271 Participants
n=107 Participants
|
238 Participants
n=206 Participants
|
3520 Participants
n=7 Participants
|
2011 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
69 Participants
n=7 Participants
|
44 Participants
n=99 Participants
|
|
Region of Enrollment
Europe
|
98 participants
n=107 Participants
|
18 participants
n=206 Participants
|
270 participants
n=7 Participants
|
154 participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1222 participants
n=107 Participants
|
229 participants
n=206 Participants
|
3386 participants
n=7 Participants
|
1935 participants
n=99 Participants
|
|
adenoma diameter
|
26 mm
n=107 Participants
|
29 mm
n=206 Participants
|
22 mm
n=7 Participants
|
20 mm
n=99 Participants
|
PRIMARY outcome
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.death
Outcome measures
| Measure |
Non-functioning Adenoma
n=2089 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L
|
Adenoma With Possible Autonomous Cortisol Secretion
n=1320 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L
|
Adenoma With Autonomous Cortisol Secretion
n=247 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test: \> 138 nmol/L
|
|---|---|---|---|
|
Mortality
|
143 Participants
|
168 Participants
|
41 Participants
|
SECONDARY outcome
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.Population: The number of analyzed patients is slightly smaller than the total cohort, because for some patients no data on cardiovascular outcome were available.
Cardiovascular (CV) events (myocardial infarction, percutaneous coronary intervention, coronary bypass, stroke, deep vein thrombosis, and pulmonary embolism)
Outcome measures
| Measure |
Non-functioning Adenoma
n=1892 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L
|
Adenoma With Possible Autonomous Cortisol Secretion
n=1208 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L
|
Adenoma With Autonomous Cortisol Secretion
n=225 Participants
cortisol values after an overnight 1 mg dexamethasone suppression test: \> 138 nmol/L
|
|---|---|---|---|
|
Cardiovascular Morbidity
|
145 Participants
|
130 Participants
|
22 Participants
|
Adverse Events
Non-functioning Adenoma
Serious events: 145 serious events
Other events: 724 other events
Deaths: 143 deaths
Adenoma With Possible Autonomous Cortisol Secretion
Serious events: 130 serious events
Other events: 547 other events
Deaths: 168 deaths
Adenoma With Autonomous Cortisol Secretion
Serious events: 22 serious events
Other events: 123 other events
Deaths: 41 deaths
Serious adverse events
| Measure |
Non-functioning Adenoma
n=2002 participants at risk；n=1892 participants at risk
cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L
|
Adenoma With Possible Autonomous Cortisol Secretion
n=1250 participants at risk；n=1208 participants at risk
cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L
|
Adenoma With Autonomous Cortisol Secretion
n=232 participants at risk；n=225 participants at risk
cortisol values after an overnight 1 mg dexamethasone suppression test: \> 138 nmol/L
|
|---|---|---|---|
|
Cardiac disorders
MACE
|
7.7%
145/1892 • 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.
Serious adverse events are defined major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death. Time frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.
|
10.8%
130/1208 • 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.
Serious adverse events are defined major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death. Time frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.
|
9.8%
22/225 • 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.
Serious adverse events are defined major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death. Time frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.
|
Other adverse events
| Measure |
Non-functioning Adenoma
n=2002 participants at risk；n=1892 participants at risk
cortisol values after an overnight 1 mg dexamethasone suppression test; less than 50 nmol/L
|
Adenoma With Possible Autonomous Cortisol Secretion
n=1250 participants at risk；n=1208 participants at risk
cortisol values after an overnight 1 mg dexamethasone suppression test: 50-138 nmol/L
|
Adenoma With Autonomous Cortisol Secretion
n=232 participants at risk；n=225 participants at risk
cortisol values after an overnight 1 mg dexamethasone suppression test: \> 138 nmol/L
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Dylipidemia
|
36.2%
724/2002 • 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.
Serious adverse events are defined major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death. Time frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.
|
43.8%
547/1250 • 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.
Serious adverse events are defined major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death. Time frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.
|
53.0%
123/232 • 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.
Serious adverse events are defined major adverse cardiovascular events (MACE): myocardial infarction or coronary revascularisation (either bypass surgery or percutaneous intervention), stroke, or cardiovascular-related death. Time frame for MACE was defined as the time between the initial diagnosis of the adrenal incidentaloma and first documentation of any MACE thereafter.
|
Additional Information
Prof Dr. Martin Fassnacht
University Hospital Würzburg
Phone: 4993120139021
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place