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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected Cushing Disease |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood test | Diagnostic Test | Plasma cortisol level test |
| |
| 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) |
| 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 |
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Inclusion Criteria:
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
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The target population of the study is patients suspected of hypercorticism. The study's source population will correspond to all patients (men and women) between the ages of 18 and 65 hospitalized in the metabolic and endocrine disorders department of CHU Nîmes for hypercorticism assessment in primary diagnosis or in a follow-up report.
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| Name | Affiliation | Role |
|---|---|---|
| David de Brauwere | CHU Nimes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Nimes | Nîmes | 30029 | France |
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| 24-hour Urine test |
| Diagnostic Test |
Urinary free cortisol test |
|
| Saliva swab | Diagnostic Test | salivette® for salivary cortisol quantification |
|
| Dexamethasone test | Diagnostic Test | Dectancyl® 2 x 0.5 mg tablets (total 1 mg) |
|
| 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 |
| ID | Term |
|---|---|
| D047748 | Pituitary ACTH Hypersecretion |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D010900 | Pituitary Diseases |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| D016482 | Urinalysis |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D019963 | Clinical Chemistry Tests |
| D003950 | Diagnostic Techniques, Urological |
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