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

Cortisol Assessment in Patients With Adrenal Incidentalomas

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07350031

Acronym

SALICOR

Enrollment

209

Registered

2026-01-20

Start date

2016-11-24

Completion date

2024-04-26

Last updated

2026-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adrenal Incidentaloma, Hypercortisolism

Keywords

Salivary cortisol, DST, MACS, hypercortisolism, reference interval

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.

Interventions

DIAGNOSTIC_TEST1 mg overnight dexamethasone suppression 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 design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

(patients): * 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). Inclusion Criteria (controls): * age ≥ 18 years, no previous history of conditions involving the adrenal glands

Exclusion criteria

(patients): * 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.

Design outcomes

Primary

Measure	Time frame	Description
Salivary cortisol and cortisone in patients and controls following an overnight dexamethasone suppression test	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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 6, 2026