Clinical trial NCT03974789: Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms
Official title: Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cushing Disease
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2019-06-05
Enrollment: 380
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Salivary cortisol measured by Roche Elecsys cortisol kit
timeFrame: Day 1 (at screening)
measure: Salivary cortisol measured by IDS cortisol dosing kit at screening
timeFrame: Day 1 (at screening)
Secondary outcomes:
measure: Salivary cortisol measured by Roche Elecsys cortisol kit
timeFrame: Day 2 and Day 3
measure: Salivary cortisol measured by IDS cortisol dosing kit
timeFrame: Day 2 and Day 3
measure: Salivary cortisol measured measured by LC-MS/MS
timeFrame: Day 1, 2 and 3
measure: Dexamethasone suppression test
timeFrame: Day 4
measure: Diurnal variation of plasma cortisol
timeFrame: Day 3
measure: Urinary free cortisol
timeFrame: Day 3
Other outcomes:
Locations:
city: Nîmes
country: France
facility: CHU de Nimes
Study officials:
affiliation: CHU Nimes
name: David de Brauwere
role: PRINCIPAL_INVESTIGATOR
References: