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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03974789
Other study ID # NIMAO/2018-03/DPDB-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date July 2025

Study information

Verified date June 2024
Source Centre Hospitalier Universitaire de Nimes
Contact David-Paul de Brauwere
Phone 04.66.68.68.42
Email david.paul.de.brauwere@chu-nimes.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 380
Est. completion date July 2025
Est. primary completion date July 2025
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
Blood test
Plasma cortisol level test
24-hour Urine test
Urinary free cortisol test
Saliva swab
salivette® for salivary cortisol quantification
Dexamethasone test
Dectancyl® 2 x 0.5 mg tablets (total 1 mg)

Locations

Country Name City State
France CHU de Nimes Nîmes

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Salivary cortisol measured by Roche Elecsys cortisol kit nmol/l Day 1 (at screening)
Primary Salivary cortisol measured by IDS cortisol dosing kit at screening nmol/l Day 1 (at screening)
Secondary Salivary cortisol measured by Roche Elecsys cortisol kit nmol/l Day 2 and Day 3
Secondary Salivary cortisol measured by IDS cortisol dosing kit nmol/l Day 2 and Day 3
Secondary Salivary cortisol measured measured by LC-MS/MS nmol/l Day 1, 2 and 3
Secondary Dexamethasone suppression test µg/l and nmol/l (cut-off for diagnosis: 50nmol/l) Day 4
Secondary Diurnal variation of plasma cortisol Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l) Day 3
Secondary Urinary free cortisol Radioimmunoassay; µg/l and nmol/l Day 3
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