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

Centre Hospitalier Universitaire de Nīmes

Status: Active, not recruiting

Conditions: Cushing Disease

Treatments: Diagnostic Test: 24-hour Urine test; Diagnostic Test: Blood test; Diagnostic Test: Saliva swab; Diagnostic Test: Dexamethasone test

Study type: Observational

Funder types: Other

Identifiers

NCT03974789

NIMAO/2018-03/DPDB-01

Details and patient eligibility

About

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).

Enrollment: 380 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

380 participants in 1 patient group

Suspected Cushing Disease

Treatment:

Diagnostic Test: Dexamethasone test

Diagnostic Test: Saliva swab

Diagnostic Test: Blood test

Diagnostic Test: 24-hour Urine test