|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
20 February 2023 |
|
Main ID: |
NCT03974789 |
|
Date of registration:
|
03/06/2019 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms
COSHING |
|
Scientific title:
|
Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study |
|
Date of first enrolment:
|
July 1, 2019 |
|
Target sample size:
|
380 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03974789 |
|
Study type:
|
Observational |
|
Study design:
|
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
France
| | | | | | | |
|
Contacts
|
|
Name:
|
Anissa Megzari |
|
Address:
|
|
|
Telephone:
|
04.66.68.42.36 |
|
Email:
|
drc@chu-nimes.fr |
|
Affiliation:
|
|
|
|
Name:
|
David de Brauwere |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
CHU Nimes |
|
|
Name:
|
David-Paul de Brauwere |
|
Address:
|
|
|
Telephone:
|
04.66.68.68.42 |
|
Email:
|
david.paul.de.brauwere@chu-nimes.fr |
|
Affiliation:
|
|
|
|
Key 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Cushing Disease
|
|
Intervention(s)
|
|
Diagnostic Test: Dexamethasone test
|
|
Diagnostic Test: 24-hour Urine test
|
|
Diagnostic Test: Saliva swab
|
|
Diagnostic Test: Blood test
|
|
Primary Outcome(s)
|
|
Salivary cortisol measured by IDS cortisol dosing kit at screening
[Time Frame: Day 1 (at screening)]
|
|
Salivary cortisol measured by Roche Elecsys cortisol kit
[Time Frame: Day 1 (at screening)]
|
|
Secondary Outcome(s)
|
|
Diurnal variation of plasma cortisol
[Time Frame: Day 3]
|
|
Salivary cortisol measured by Roche Elecsys cortisol kit
[Time Frame: Day 2 and Day 3]
|
|
Salivary cortisol measured measured by LC-MS/MS
[Time Frame: Day 1, 2 and 3]
|
|
Dexamethasone suppression test
[Time Frame: Day 4]
|
|
Urinary free cortisol
[Time Frame: Day 3]
|
|
Salivary cortisol measured by IDS cortisol dosing kit
[Time Frame: Day 2 and Day 3]
|
|
Secondary ID(s)
|
|
NIMAO/2018-03/DPDB-01
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|