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

Cushing Disease Clinical Trial

— COSHING  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03974789
• Other study ID #: NIMAO/2018-03/DPDB-01
• Status: Recruiting
• Start date: July 1, 2019
• Est. completion date: July 2025

Study information

• Verified date: February 2023
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: David-Paul de Brauwere
• Phone: 04.66.68.68.42
• Email: david.paul.de.brauwere[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ACTH-Secreting Pituitary Adenoma
• Adrenocortical Hyperfunction
• Cushing Disease
• Pituitary ACTH Hypersecretion

Intervention

Diagnostic Test:
• Blood test
Plasma cortisol level test
• 24-hour Urine test
Urinary free cortisol test
• Saliva swab
salivette® for salivary cortisol quantification
• Dexamethasone test
Dectancyl® 2 x 0.5 mg tablets (total 1 mg)

Locations

Country	Name	City	State
France	CHU de Nimes	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary cortisol measured by Roche Elecsys cortisol kit	nmol/l	Day 1 (at screening)
Primary	Salivary cortisol measured by IDS cortisol dosing kit at screening	nmol/l	Day 1 (at screening)
Secondary	Salivary cortisol measured by Roche Elecsys cortisol kit	nmol/l	Day 2 and Day 3
Secondary	Salivary cortisol measured by IDS cortisol dosing kit	nmol/l	Day 2 and Day 3
Secondary	Salivary cortisol measured measured by LC-MS/MS	nmol/l	Day 1, 2 and 3
Secondary	Dexamethasone suppression test	µg/l and nmol/l (cut-off for diagnosis: 50nmol/l)	Day 4
Secondary	Diurnal variation of plasma cortisol	Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l)	Day 3
Secondary	Urinary free cortisol	Radioimmunoassay; µg/l and nmol/l	Day 3