NCT03974789

Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms

Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 380 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Automated immunodosage methods (Roche Elecsys cortisol and IDS cortisol dosing kits) offer a simple and inexpensive technology routinely used in a medical biology laboratory. They can be used to define robust diagnostic thresholds for salivary cortisol for the diagnosis of Cushing's syndrome and pseudo-Cushing combining the three tests performed as part of the patient's usual management. (ie two urinary free cortisol (UFC), the dexamethasone suppression test, and Diurnal variation of plasma cortisol).

Conditions

• Cushing Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood test	Plasma cortisol level test
DIAGNOSTIC_TEST	24-hour Urine test	Urinary free cortisol test
DIAGNOSTIC_TEST	Saliva swab	salivette® for salivary cortisol quantification
DIAGNOSTIC_TEST	Dexamethasone test	Dectancyl® 2 x 0.5 mg tablets (total 1 mg)

Timeline

• Start date: 2019-07-01
• Primary completion: 2025-07-01
• Completion: 2026-07-01
• First posted: 2019-06-05
• Last updated: 2025-11-17

Locations

1 site across 1 country: France