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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03974789
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Centre Hospitalier Universitaire de Nīmes
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

David de Brauwere
Principal Investigator Affiliation CHU Nimes
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Cushing Disease
Arms & Interventions

Arms

: Suspected Cushing Disease

Interventions

Diagnostic Test: - Blood test

Plasma cortisol level test

Diagnostic Test: - 24-hour Urine test

Urinary free cortisol test

Diagnostic Test: - Saliva swab

salivette® for salivary cortisol quantification

Diagnostic Test: - Dexamethasone test

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Nimes, Nîmes, France

Status

Recruiting

Address

CHU de Nimes

Nîmes, , 30029

Site Contact

Anissa Megzari

[email protected]

04.66.68.42.36

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