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

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ClinicalTrials.gov Identifier: NCT03974789
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : October 5, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Tracking Information
First Submitted Date June 3, 2019
First Posted Date June 5, 2019
Last Update Posted Date October 5, 2021
Actual Study Start Date July 1, 2019
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 3, 2019)
  • Salivary cortisol measured by Roche Elecsys cortisol kit [ Time Frame: Day 1 (at screening) ]
    nmol/l
  • Salivary cortisol measured by IDS cortisol dosing kit at screening [ Time Frame: Day 1 (at screening) ]
    nmol/l
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 3, 2019)
  • Salivary cortisol measured by Roche Elecsys cortisol kit [ Time Frame: Day 2 and Day 3 ]
    nmol/l
  • Salivary cortisol measured by IDS cortisol dosing kit [ Time Frame: Day 2 and Day 3 ]
    nmol/l
  • Salivary cortisol measured measured by LC-MS/MS [ Time Frame: Day 1, 2 and 3 ]
    nmol/l
  • Dexamethasone suppression test [ Time Frame: Day 4 ]
    µg/l and nmol/l (cut-off for diagnosis: 50nmol/l)
  • Diurnal variation of plasma cortisol [ Time Frame: Day 3 ]
    Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l)
  • Urinary free cortisol [ Time Frame: Day 3 ]
    Radioimmunoassay; µg/l and nmol/l
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms
Official Title Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study
Brief 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).
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The target population of the study is patients suspected of hypercorticism. The study's source population will correspond to all patients (men and women) between the ages of 18 and 65 hospitalized in the metabolic and endocrine disorders department of CHU Nîmes for hypercorticism assessment in primary diagnosis or in a follow-up report.
Condition Cushing Disease
Intervention
  • 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)
Study Groups/Cohorts Suspected Cushing Disease
Interventions:
  • Diagnostic Test: Blood test
  • Diagnostic Test: 24-hour Urine test
  • Diagnostic Test: Saliva swab
  • Diagnostic Test: Dexamethasone test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 3, 2019)
380
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2025
Estimated Primary Completion Date July 2025   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts
Contact: David-Paul de Brauwere 04.66.68.68.42 david.paul.de.brauwere@chu-nimes.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT03974789
Other Study ID Numbers NIMAO/2018-03/DPDB-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire de Nīmes
Study Sponsor Centre Hospitalier Universitaire de Nīmes
Collaborators Not Provided
Investigators
Principal Investigator: David de Brauwere CHU Nimes
PRS Account Centre Hospitalier Universitaire de Nīmes
Verification Date October 2021