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Trial record 4 of 5 for:    "Acth-Secreting Pituitary Adenoma" | "glucocorticoids"

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 : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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).

Condition or disease Intervention/treatment
Cushing Disease Diagnostic Test: Blood test Diagnostic Test: 24-hour Urine test Diagnostic Test: Saliva swab Diagnostic Test: Dexamethasone test

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Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021


Group/Cohort Intervention/treatment
Suspected Cushing Disease 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)




Primary Outcome Measures :
  1. Salivary cortisol measured by Roche Elecsys cortisol kit [ Time Frame: Day 1 (at screening) ]
    nmol/l

  2. Salivary cortisol measured by IDS cortisol dosing kit at screening [ Time Frame: Day 1 (at screening) ]
    nmol/l


Secondary Outcome Measures :
  1. Salivary cortisol measured by Roche Elecsys cortisol kit [ Time Frame: Day 2 and Day 3 ]
    nmol/l

  2. Salivary cortisol measured by IDS cortisol dosing kit [ Time Frame: Day 2 and Day 3 ]
    nmol/l

  3. Salivary cortisol measured measured by LC-MS/MS [ Time Frame: Day 1, 2 and 3 ]
    nmol/l

  4. Dexamethasone suppression test [ Time Frame: Day 4 ]
    µg/l and nmol/l (cut-off for diagnosis: 50nmol/l)

  5. Diurnal variation of plasma cortisol [ Time Frame: Day 3 ]
    Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l)

  6. Urinary free cortisol [ Time Frame: Day 3 ]
    Radioimmunoassay; µg/l and nmol/l



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974789


Contacts
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Contact: David-Paul de Brauwere 04.66.68.68.42 david.paul.de.brauwere@chu-nimes.fr

Locations
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France
CHU de Nimes Recruiting
Nîmes, France, 30029
Contact: Anissa Megzari    04.66.68.42.36    drc@chu-nimes.fr   
Principal Investigator: David-Paul de Brauwere         
Sub-Investigator: Léonore Zagdoun         
Sub-Investigator: Serge Lumbroso         
Sub-Investigator: Anne-Marie Guedj         
Sub-Investigator: Véronique Taillard         
Sub-Investigator: Olivier Gilly         
Sub-Investigator: Valéria Soma         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Principal Investigator: David de Brauwere CHU Nimes

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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT03974789     History of Changes
Other Study ID Numbers: NIMAO/2018-03/DPDB-01
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma
Glucocorticoids
Pituitary ACTH Hypersecretion
Adrenocortical Hyperfunction
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Adrenal Gland Diseases
Dexamethasone
Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents