Cushing Disease
Conditions
Brief 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).
Interventions
DIAGNOSTIC_TESTBlood test
Plasma cortisol level test
DIAGNOSTIC_TEST24-hour Urine test
Urinary free cortisol test
DIAGNOSTIC_TESTSaliva swab
salivette® for salivary cortisol quantification
DIAGNOSTIC_TESTDexamethasone test
Dectancyl® 2 x 0.5 mg tablets (total 1 mg)
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Salivary cortisol measured by Roche Elecsys cortisol kit | Day 1 (at screening) | nmol/l |
| Salivary cortisol measured by IDS cortisol dosing kit at screening | Day 1 (at screening) | nmol/l |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary cortisol measured measured by LC-MS/MS | Day 1, 2 and 3 | nmol/l |
| Dexamethasone suppression test | Day 4 | µg/l and nmol/l (cut-off for diagnosis: 50nmol/l) |
| Salivary cortisol measured by Roche Elecsys cortisol kit | Day 2 and Day 3 | nmol/l |
| Urinary free cortisol | Day 3 | Radioimmunoassay; µg/l and nmol/l |
| Diurnal variation of plasma cortisol | Day 3 | Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l) |
| Salivary cortisol measured by IDS cortisol dosing kit | Day 2 and Day 3 | nmol/l |
Countries
France
Outcome results
None listed