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: 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 (Anticipated): 380

Contacts and Locations

• Study Contact: Name: David-Paul de Brauwere; Phone Number: 04.66.68.68.42; Email: david.paul.de.brauwere@chu-nimes.fr

Study Locations

• France
  • Nîmes, France, 30029
    • Recruiting
    • CHU de Nîmes
    • Principal Investigator: David-Paul de Brauwere
    • Sub-Investigator: Léonore Zagdoun
    • Sub-Investigator: Véronique Taillard
    • Sub-Investigator: Olivier Gilly
    • Sub-Investigator: Valéria Soma
    • Principal Investigator: Fanchon Huguet

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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 (ANTICIPATED): July 1, 2025
• Study Completion (ANTICIPATED): July 1, 2025

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 (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Hypothalamic Diseases; Hyperpituitarism; Pituitary Diseases; Adenoma; Adrenal Gland Diseases; Pituitary Neoplasms; Adrenocortical Hyperfunction; ACTH-Secreting Pituitary Adenoma; Pituitary ACTH Hypersecretion; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone
• 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