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Active, Not Recruiting

NCT Number: NCT03974789

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

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Cushing Disease Brain Diseases Central Nervous System Diseases Endocrine System Diseases Hyperpituitarism Hypothalamic Diseases Nervous System Diseases Pituitary ACTH Hypersecretion Pituitary Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Nimes

Nîmes, 30029, France

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood test

Diagnostic Test

Plasma cortisol level test

24-hour Urine test

Diagnostic Test

Urinary free cortisol test

Saliva swab

Diagnostic Test

salivette® for salivary cortisol quantification

Dexamethasone test

Diagnostic Test

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

Primary outcomes

  1. Salivary cortisol measured by Roche Elecsys cortisol kit

    Time frame: Day 1 (at screening)

    nmol/l

  2. Salivary cortisol measured by IDS cortisol dosing kit at screening

    Time frame: Day 1 (at screening)

    nmol/l

Secondary outcomes

  1. Salivary cortisol measured by Roche Elecsys cortisol kit

    Time frame: Day 2 and Day 3

    nmol/l

  2. Salivary cortisol measured by IDS cortisol dosing kit

    Time frame: Day 2 and Day 3

    nmol/l

  3. Salivary cortisol measured measured by LC-MS/MS

    Time frame: Day 1, 2 and 3

    nmol/l

  4. Dexamethasone suppression test

    Time frame: Day 4

    µg/l and nmol/l (cut-off for diagnosis: 50nmol/l)

  5. Diurnal variation of plasma cortisol

    Time frame: Day 3

    Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l)

  6. Urinary free cortisol

    Time frame: Day 3

    Radioimmunoassay; µg/l and nmol/l

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

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

Acronym: COSHING

Important dates

Study start
2019
Primary completion
2025
Study completion
2026
First posted
Jun 5, 2019
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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