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

Last updated: June 4, 2024
Sponsor: Centre Hospitalier Universitaire de Nīmes
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cushing's Disease

Treatment

Blood test

Saliva swab

24-hour Urine test

Clinical Study ID

NCT03974789
NIMAO/2018-03/DPDB-01
  • Ages > 18
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The patient is under consultation in the department of metabolic and endocrinedisorders 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

Exclusion Criteria:

  • The patient is pregnant, parturient or breastfeeding

  • The patient has a cardiovascular or metabolic state against the indication ofdexamethasone

  • Patient with DFG < 30 ml/min/1.73 m2

  • The patient has suffered urinary incontinence rendering 24-hour urinary collectionimpossible 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, megestrolacetate, 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

Study Design

Total Participants: 380
Treatment Group(s): 4
Primary Treatment: Blood test
Phase:
Study Start date:
July 01, 2019
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • CHU de Nimes

    Nîmes, 30029
    France

    Active - Recruiting

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