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

Recruiting

• Conditions: Cushing Disease
• Interventions: Diagnostic Test: Blood test; Diagnostic Test: 24-hour Urine test; Diagnostic Test: Saliva swab; Diagnostic Test: Dexamethasone test

• Registration Number: NCT03974789
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-03
• Study First Submitted QC: 2019-06-03
• Study First Posted: 2019-06-05
• Study Start: 2019-07-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-04
• Last Update Posted: 2024-06-05
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 380

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected Cushing Disease	Saliva swab	-
Suspected Cushing Disease	Dexamethasone test	-
Suspected Cushing Disease	24-hour Urine test	-
Suspected Cushing Disease	Blood test	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Salivary cortisol measured by Roche Elecsys cortisol kit	Day 2 and Day 3	nmol/l
Salivary cortisol measured by IDS cortisol dosing kit	Day 2 and Day 3	nmol/l
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)
Diurnal variation of plasma cortisol	Day 3	Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l)
Urinary free cortisol	Day 3	Radioimmunoassay; µg/l and nmol/l

Trial Locations

Locations (1)

CHU de Nimes; 🇫🇷 Nîmes, France