Using salivary cortisol tests to diagnose Cushing's syndrome
Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study
Centre Hospitalier Universitaire de Nīmes · NCT03974789
This study is testing a new way to use saliva samples to help doctors diagnose Cushing's syndrome more accurately in patients who might have it.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 380 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire de Nīmes (other) |
| Locations | 1 site (Nîmes) |
| Trial ID | NCT03974789 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the effectiveness of automated immunoassay methods for measuring salivary cortisol levels in diagnosing Cushing's syndrome and pseudo-Cushing. It combines results from multiple tests, including urinary free cortisol, the dexamethasone suppression test, and diurnal plasma cortisol variation, to establish reliable diagnostic thresholds. The study aims to simplify and enhance the diagnostic process for patients suspected of having hypercortisolism.
Who should consider this trial
Good fit: Ideal candidates are patients consulting for hypercortisol assessment in the metabolic and endocrine disorders department at CHU Nîmes.
Not a fit: Patients who are pregnant, have certain cardiovascular or metabolic conditions, or are taking specific medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and accessible diagnosis of Cushing's syndrome, improving patient outcomes.
How similar studies have performed: Other studies have shown promise in using similar diagnostic approaches, but this specific methodology may offer novel insights.
Eligibility criteria
Show full 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
Where this trial is running
Nîmes
- CHU de Nimes — Nîmes, France (RECRUITING)
Study contacts
- Principal investigator: David de Brauwere — CHU Nimes
- Study coordinator: David-Paul de Brauwere
- Email: david.paul.de.brauwere@chu-nimes.fr
- Phone: 04.66.68.68.42
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cushing Disease