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

Study Overview
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Brief Summary
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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).

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

Conditions
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Cushing Disease

Intervention / Treatment
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* Diagnostic Test: Blood test
* Diagnostic Test: 24-hour Urine test
* Diagnostic Test: Saliva swab
* Diagnostic Test: Dexamethasone test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient is under consultation in the department of metabolic and endocrine disorders at the CHU Nimes for diagnosis or follow-up of hypercortisol assessment The patient must be a member or beneficiary of a health insurance plan Exclusion Criteria: The patient is pregnant, parturient or breastfeeding The patient has a cardiovascular or metabolic state against the indication of dexamethasone - Patient with DFG < 30 ml/min/1.73 m2 The patient has suffered urinary incontinence rendering 24-hour urinary collection impossible or non-interpretable The patient has a urinary catheter The patient is taking corticoids (oral, inhaled, intra-venous or cutaneous) .Patient exposed to interfering treatments (Itraconazole, ritonavir, megestrol acetate, medroxyprogesterone acetate, TSH, estrogen-progestogen pill, hormonal coil) The subject is in a period of exclusion determined by a previous study The subject opposes their participation in the study It is impossible to give the subject informed information The patient is under safeguard of justice or state guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected Cushing Disease<br> | Diagnostic Test: Blood test<br>* Plasma cortisol level test<br>Diagnostic Test: 24-hour Urine test<br>* Urinary free cortisol test<br>Diagnostic Test: Saliva swab<br>* salivette® for salivary cortisol quantification<br>Diagnostic Test: Dexamethasone test<br>* Dectancyl® 2 x 0.5 mg tablets (total 1 mg)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cortisol measured by Roche Elecsys cortisol kit | nmol/l | Day 1 (at screening) | 
| Salivary cortisol measured by IDS cortisol dosing kit at screening | nmol/l | Day 1 (at screening) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cortisol measured by Roche Elecsys cortisol kit | nmol/l | Day 2 and Day 3 | 
| Salivary cortisol measured by IDS cortisol dosing kit | nmol/l | Day 2 and Day 3 | 
| Salivary cortisol measured measured by LC-MS/MS | nmol/l | Day 1, 2 and 3 | 
| Dexamethasone suppression test | µg/l and nmol/l (cut-off for diagnosis: 50nmol/l) | Day 4 | 
| Diurnal variation of plasma cortisol | Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l) | Day 3 | 
| Urinary free cortisol | Radioimmunoassay; µg/l and nmol/l | Day 3 |