Adrenal IncidentalomaSALICORNCT07350031
Serum and Salivary Cortisol Assessment in Patients With Adrenal Incidentalomas and Healthy Controls
An observational study of Adrenal Incidentaloma and Hypercortisolism, run by Copenhagen University Hospital, Rigshospitalet.
Trial summary
The goal of this observational study is to evaluate the diagnostic accuracy of salivary cortisol compared with serum cortisol after a 1 mg overnight dexamethasone suppression test in participants (N = 100) with adrenal incidentalomas and healthy control participants (N = 100). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adrenal Incidentaloma, Hypercortisolism
- What is being tested?
- 1 mg overnight dexamethasone suppression test
- How many people
- 209 participants
- Where
- No sites listed yet
- Study dates
- 24 Nov 2016to 26 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patient group were patients newly diagnosed with an adrenal incidentaloma and referred to either the Department of Nephrology and Endocrinology, Copenhagen University Hospital, Rigshospi-talet, Denmark or Department of Medicine, Copenhagen University Hospital Herlev Gentofte, Herlev, Denmark. The controls were recruited through social media, online participant recruitment platform , the hospital website, and physical posters in public spaces around Copenhagen, Denmark.
Who may be able to join
- age ≥ 18 years, a new diagnosis of an adrenal incidentaloma (defined as an adrenal mass > 1 cm detected when using diagnostic imaging for non-related reasons).
- age ≥ 18 years, no previous history of conditions involving the adrenal glands
Who cannot join
- active cancer; an adrenal incidentaloma suspected of malignancy; bilateral adrenal incidentalomas; pregnancy and breastfeeding; conditions or medical treatments that interfere with dexamethasone metabolism and cortisol metabolism/measurements; severe comorbidities; chronic kidney disease (defined as an estimated glomerular filtration rate < 60 ml/min); and inability to provide written informed consent.
- active cancer; pregnancy and breastfeeding; conditions or medical treatments that interfere with dexamethasone metabolism and cortisol metabolism/measurements; severe comorbidities; chronic kidney disease (defined as an estimated glomerular filtration rate < 60 ml/min); and inability to provide written informed consent.
About this study
Official title: Cortisol Assessment in Patients With Adrenal Incidentalomas
The goal of this observational study is to evaluate the diagnostic accuracy of salivary cortisol compared with serum cortisol after a 1 mg overnight dexamethasone suppression test in participants (N = 100) with adrenal incidentalomas and healthy control participants (N = 100). The main question it aims to answer is:
Are salivary cortisol and serum cortisol equal diagnostic tools for endogenous hypercortisolism?
Read more
The inclusion of healthy controls will serve as a reference population to define the central 95 % reference interval for the serum and salivary cortisol levels.
Participants will undergo routine medical examination of adrenal incidentalomas including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol.
- Conditions
- Adrenal Incidentaloma, Hypercortisolism
- Being tested
- 1 mg overnight dexamethasone suppression test
- Keywords
- Salivary cortisol, DST, MACS, hypercortisolism, reference interval
- Medical subject headings
- Adrenal incidentaloma, Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1 mg overnight dexamethasone suppression testDiagnostic test
Included participants will undergo routine medical examination including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol.
| Study group | Role | What they receive |
|---|---|---|
| Patients with adrenal incidentalomas | Not described Receives: Diagnostic Test: 1 mg overnight dexamethasone suppression test | |
| Healthy control group | Not described Receives: Diagnostic Test: 1 mg overnight dexamethasone suppression test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol and cortisone in patients and controls following an overnight dexamethasone suppression test
Cross-sectional evaluation of serum and salivary cortisol and cortisone after an overnight 1 mg dexamethasone suppression test in patients with adrenal incidentalomas and healthy controls.
Measured: Baseline (Day 0, 08:00-09:00 hour) and post-dexamethasone (Day 1, 08:00-09:00 hour)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start24 Nov 2016
- Primary completion26 Apr 2024
- Study completion26 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adrenal IncidentalomaStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev
- Responsible party
- Principal investigator, Nanna Thurmann Jørgensen, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350031
- Sponsor's protocol ID
- H-16041718
- Acronym
- SALICOR
- Status last verified
- Jan 2026
- First submitted
- 30 Sep 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortisol Assessment in Patients With Adrenal Incidentalomas
- ClinicalTrials.gov ID
- NCT07350031
- Acronym / sponsor ID
- SALICOR / H-16041718
- Conditions
- Adrenal Incidentaloma, Hypercortisolism
- Keywords
- Salivary cortisol, DST, MACS, hypercortisolism, reference interval
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 209 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital at Herlev
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- 26 Apr 2024 (actual)
- Study completion
- 26 Apr 2024 (actual)
- First posted
- 20 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the diagnostic accuracy of salivary cortisol compared with serum cortisol after a 1 mg overnight dexamethasone suppression test in participants (N = 100) with adrenal incidentalomas and healthy control participants (N = 100). The main question it aims to answer is:
Are salivary cortisol and serum cortisol equal diagnostic tools for endogenous hypercortisolism?
The inclusion of healthy controls will serve as a reference population to define the central 95 % reference interval for the serum and salivary cortisol levels.
Participants will undergo routine medical examination of adrenal incidentalomas including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with adrenal incidentalomas | – | Diagnostic Test: 1 mg overnight dexamethasone suppression test |
| Healthy control group | – | Diagnostic Test: 1 mg overnight dexamethasone suppression test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patient group were patients newly diagnosed with an adrenal incidentaloma and referred to either the Department of Nephrology and Endocrinology, Copenhagen University Hospital, Rigshospi-talet, Denmark or Department of Medicine, Copenhagen University Hospital Herlev Gentofte, Herlev, Denmark. The controls were recruited through social media, online participant recruitment platform , the hospital website, and physical posters in public spaces around Copenhagen, Denmark.
Key inclusion criteria (2 listed)
- age ≥ 18 years, a new diagnosis of an adrenal incidentaloma (defined as an adrenal mass > 1 cm detected when using diagnostic imaging for non-related reasons).
- age ≥ 18 years, no previous history of conditions involving the adrenal glands
Key exclusion criteria (2 listed)
- active cancer; an adrenal incidentaloma suspected of malignancy; bilateral adrenal incidentalomas; pregnancy and breastfeeding; conditions or medical treatments that interfere with dexamethasone metabolism and cortisol metabolism/measurements; severe comorbidities; chronic kidney disease (defined as an estimated glomerular filtration rate < 60 ml/min); and inability to provide written informed consent.
- active cancer; pregnancy and breastfeeding; conditions or medical treatments that interfere with dexamethasone metabolism and cortisol metabolism/measurements; severe comorbidities; chronic kidney disease (defined as an estimated glomerular filtration rate < 60 ml/min); and inability to provide written informed consent.
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 |
|---|---|---|
| 1 mg overnight dexamethasone suppression testIncluded participants will undergo routine medical examination including 1 mg dexamethasone-suppression-test, 24 h urine sample, and measurement of plasma-adrenocorticotropin (ACTH). In addition to the routine biochemical tests, saliva samples will be collected the morning and evening before intake of dexamethasone as well as the following morning together with serum cortisol. | Diagnostic test | Healthy control group, Patients with adrenal incidentalomas |
Primary outcome
Salivary cortisol and cortisone in patients and controls following an overnight dexamethasone suppression test
Time frame: Baseline (Day 0, 08:00-09:00 hour) and post-dexamethasone (Day 1, 08:00-09:00 hour)
Cross-sectional evaluation of serum and salivary cortisol and cortisone after an overnight 1 mg dexamethasone suppression test in patients with adrenal incidentalomas and healthy controls.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Adrenal Incidentaloma and Hypercortisolism, run by Copenhagen University Hospital, Rigshospitalet.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Salivary cortisol and cortisone in patients and controls following an overnight dexamethasone suppression test (time frame: Baseline (Day 0, 08:00-09:00 hour) and post-dexamethasone (Day 1, 08:00-09:00 hour)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.