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

NCT03974789 | Active Not Recruiting

• 1 other identifier: NIMAO/2018-03/DPDB-01
• Study Type: observational
• Target: 380
• Locations: 1 country
• Sites: 1

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).

Conditions

Cushing Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Salivary cortisol measured by Roche Elecsys cortisol kit

  Day 2 and Day 3

• Salivary cortisol measured by IDS cortisol dosing kit

  Day 2 and Day 3

• Salivary cortisol measured measured by LC-MS/MS

  Day 1, 2 and 3

• Dexamethasone suppression test

  Day 4

• Diurnal variation of plasma cortisol

  Day 3

Study Arms (1)

Suspected Cushing Disease

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

Interventions

Blood test DIAGNOSTIC_TEST

Plasma cortisol level test

Suspected Cushing Disease

24-hour Urine test DIAGNOSTIC_TEST

Urinary free cortisol test

Suspected Cushing Disease

Saliva swab DIAGNOSTIC_TEST

salivette® for salivary cortisol quantification

Suspected Cushing Disease

Dexamethasone test DIAGNOSTIC_TEST

Dectancyl® 2 x 0.5 mg tablets (total 1 mg)

Suspected Cushing Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion

Interventions

Hematologic Tests; Urinalysis

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• David de Brauwere

  CHU Nimes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2019
• First Posted: June 5, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Locations

FR (1)