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

NCT07350031 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 209

Last updated 2026-01-20

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

1 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.

Sponsors & Collaborators

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Rigshospitalet, Denmark

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-24
Primary Completion
2024-04-26
Completion
2024-04-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07350031 on ClinicalTrials.gov