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

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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Cushing Disease
• Intervention / Treatment: Diagnostic test: Blood test; Diagnostic test: 24-hour Urine test; Diagnostic test: Saliva swab; Diagnostic test: Dexamethasone test

• Study Type: Observational
• Enrollment (Estimated): 380

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • CHU de Nîmes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Suspected Cushing Disease	Diagnostic test: Blood test; Plasma cortisol level test; Diagnostic test: 24-hour Urine test; Urinary free cortisol test; Diagnostic test: Saliva swab; salivette® for salivary cortisol quantification; Diagnostic test: Dexamethasone test; Dectancyl® 2 x 0.5 mg tablets (total 1 mg)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: David de Brauwere, CHU Nîmes

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2019
• Primary Completion (Actual): July 1, 2025
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: June 3, 2019
• First Submitted That Met QC Criteria: June 3, 2019
• First Posted (Actual): June 5, 2019

Study Record Updates

• Last Update Posted (Estimated): November 17, 2025
• Last Update Submitted That Met QC Criteria: November 14, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Pituitary ACTH Hypersecretion; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Urological; Clinical Chemistry Tests; Hematologic Tests; Urinalysis
• Other Study ID Numbers: NIMAO/2018-03/DPDB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No