Serum and Salivary Cortisol Assessment in Patients With Adrenal Incidentalomas and Healthy Controls

NCT07350031 | Completed

• 1 other identifier: H-16041718
• Study Type: observational
• Target: 209
• Locations: 0 countries
• Sites: N/A

Brief 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). 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.

Conditions

Adrenal Incidentaloma; Hypercortisolism

Keywords

Salivary cortisol, DST, MACS, hypercortisolism, reference interval

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline (Day 0, 08:00-09:00 hour) and post-dexamethasone (Day 1, 08:00-09:00 hour)

Study Arms (2)

Patients with adrenal incidentalomas

Diagnostic Test: 1 mg overnight dexamethasone suppression test

Healthy control group

Diagnostic Test: 1 mg overnight dexamethasone suppression test

Interventions

1 mg overnight dexamethasone suppression test DIAGNOSTIC_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.

Healthy control group; Patients with adrenal incidentalomas

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Copenhagen University Hospital at Herlev: collaborator
• Rigshospitalet, Denmark: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma, serum, urine, saliva

MeSH Terms

Conditions

Adrenal incidentaloma; Cushing Syndrome

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 30, 2025
• First Posted: January 20, 2026
• Study Start: November 24, 2016
• Primary Completion: April 26, 2024
• Study Completion: April 26, 2024
• Last Updated: January 20, 2026

Record last verified: 2026-01