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

NCT ID: NCT03974789

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

380 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2026-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Cushing Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Suspected Cushing Disease

Blood test

Intervention Type DIAGNOSTIC_TEST

Plasma cortisol level test

24-hour Urine test

Intervention Type DIAGNOSTIC_TEST

Urinary free cortisol test

Saliva swab

Intervention Type DIAGNOSTIC_TEST

salivette® for salivary cortisol quantification

Dexamethasone test

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Blood test

Plasma cortisol level test

Intervention Type DIAGNOSTIC_TEST

24-hour Urine test

Urinary free cortisol test

Intervention Type DIAGNOSTIC_TEST

Saliva swab

salivette® for salivary cortisol quantification

Intervention Type DIAGNOSTIC_TEST

Dexamethasone test

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nīmes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David de Brauwere

Role: PRINCIPAL_INVESTIGATOR

CHU Nimes

Locations

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CHU de Nimes

Nîmes, , France

Site Status

Countries

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France

Other Identifiers

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NIMAO/2018-03/DPDB-01

Identifier Type: -

Identifier Source: org_study_id

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