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Active, not recruitingNCT03974789COSHINGUpdated Nov 17, 2025

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

An observational study in Cushing Disease, sponsored by Centre Hospitalier Universitaire de Nīmes. Active, not recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Centre Hospitalier Universitaire de Nīmes · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
380
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Cushing Disease
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In context

Pituitary ACTH Hypersecretion

64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.

This study's planned enrollment of 380 is above the median of 131 across 20 observational studies indexed under Pituitary ACTH Hypersecretion.

Browse Pituitary ACTH Hypersecretion studies →

Lead sponsor

Centre Hospitalier Universitaire de Nīmes is the lead sponsor of 595 studies on the registry; 90 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
380 participants (estimated)
Patient registry
No

Groups and cohorts

  • Suspected Cushing Disease

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

Interventions

  • Diagnostic testBlood test

    Plasma cortisol level test

  • Diagnostic test24-hour Urine test

    Urinary free cortisol test

  • Diagnostic testSaliva swab

    salivette® for salivary cortisol quantification

  • Diagnostic testDexamethasone test

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

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What researchers measure

Primary outcomes

  1. Salivary cortisol measured by Roche Elecsys cortisol kit

    nmol/l

    Time frame: Day 1 (at screening)

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

    nmol/l

    Time frame: Day 1 (at screening)

Secondary outcomes

  1. Salivary cortisol measured by Roche Elecsys cortisol kit

    nmol/l

    Time frame: Day 2 and Day 3

  2. Salivary cortisol measured by IDS cortisol dosing kit

    nmol/l

    Time frame: Day 2 and Day 3

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

    nmol/l

    Time frame: Day 1, 2 and 3

  4. Dexamethasone suppression test

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

    Time frame: Day 4

  5. Diurnal variation of plasma cortisol

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

    Time frame: Day 3

  6. Urinary free cortisol

    Radioimmunoassay; µg/l and nmol/l

    Time frame: Day 3

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Study locations

1 site
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03974789
Responsible party
Sponsor
First posted
Jun 5, 2019
Start date
Jul 1, 2019
Primary completion
Jul 1, 2025
Completion
Jul 2026 (estimated)
Last update
Nov 17, 2025

Study contacts

David de Brauwere
principal investigator · CHU Nimes

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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