Cushing DiseaseCOSHINGNCT03974789
Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms
An observational study of Cushing Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing Disease
- What is being tested?
- Blood test, 24-hour Urine test and Saliva swab
- Type of treatment
- Pill or oral medicine
- How many people
- 380 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2019to Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Show all 11Show fewer
- .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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study
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).
- Conditions
- Cushing Disease
- Being tested
- Blood test, 24-hour Urine test, Saliva swab, Dexamethasone test
- Medical subject headings
- Pituitary ACTH Hypersecretion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood testDiagnostic test
Plasma cortisol level test
24-hour Urine testDiagnostic test
Urinary free cortisol test
Saliva swabDiagnostic test
salivette® for salivary cortisol quantification
Dexamethasone testDiagnostic test
Dectancyl® 2 x 0.5 mg tablets (total 1 mg)
| Study group | Role | What they receive |
|---|---|---|
| Suspected Cushing Disease | Not described Receives: Diagnostic Test: Blood test; Diagnostic Test: 24-hour Urine test; Diagnostic Test: Saliva swab; Diagnostic Test: Dexamethasone test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol measured by Roche Elecsys cortisol kit
nmol/l
Measured: Day 1 (at screening)
Salivary cortisol measured by IDS cortisol dosing kit at screening
nmol/l
Measured: Day 1 (at screening)
Secondary outcomes (6)
Salivary cortisol measured by Roche Elecsys cortisol kit
nmol/l
Measured: Day 2 and Day 3
Salivary cortisol measured by IDS cortisol dosing kit
nmol/l
Measured: Day 2 and Day 3
Salivary cortisol measured measured by LC-MS/MS
nmol/l
Measured: Day 1, 2 and 3
Dexamethasone suppression test
µg/l and nmol/l (cut-off for diagnosis: 50nmol/l)
Measured: Day 4
Diurnal variation of plasma cortisol
Roche Elecsys cortisol kiet; µg/l and nmol/l (cut-off for diagnosis: 200nmol/l)
Measured: Day 3
Urinary free cortisol
Radioimmunoassay; µg/l and nmol/l
Measured: Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jul 2019
- Primary completion1 Jul 2025
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David de Brauwere, Principal investigator, CHU Nimes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974789
- Sponsor's protocol ID
- NIMAO/2018-03/DPDB-01
- Acronym
- COSHING
- Status last verified
- Nov 2025
- First submitted
- 3 Jun 2019
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Discriminant Capacity and Thresholds of Salivary Cortisol in Chemiluminescence in the Diagnosis of Hypercorticisms: Phase III Diagnostic Evaluation Study
- ClinicalTrials.gov ID
- NCT03974789
- Acronym / sponsor ID
- COSHING / NIMAO/2018-03/DPDB-01
- Conditions
- Cushing Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected Cushing Disease | – | Diagnostic Test: Blood test, Diagnostic Test: 24-hour Urine test, Diagnostic Test: Saliva swab, Diagnostic Test: Dexamethasone test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (11 listed)
- The patient is pregnant, parturient or breastfeeding
- The patient has a cardiovascular or metabolic state against the indication of dexamethasone
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood testPlasma cortisol level test | Diagnostic test | Suspected Cushing Disease |
| 24-hour Urine testUrinary free cortisol test | Diagnostic test | Suspected Cushing Disease |
| Saliva swabsalivette® for salivary cortisol quantification | Diagnostic test | Suspected Cushing Disease |
| Dexamethasone testDectancyl® 2 x 0.5 mg tablets (total 1 mg) | Diagnostic test | Suspected Cushing Disease |
Primary outcome
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
6 secondary outcomes
Salivary cortisol measured by Roche Elecsys cortisol kit
Time frame: Day 2 and Day 3
Salivary cortisol measured by IDS cortisol dosing 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
Diurnal variation of plasma cortisol
Time frame: Day 3
Urinary free cortisol
Time frame: Day 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
Related trials for Cushing Disease
Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Not yet recruitingObservational study
Automated Capture of Core Data for Rare Diseases and Glucocorticoid Complications: Biomarkers and Patient-Reported Outcomes
Cushing s Syndrome, Glucocorticoid Effect
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 1/2
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
Cushing s Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David de Brauwere principal investigator
CHU Nimes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cushing Disease, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary cortisol measured by Roche Elecsys cortisol kit (time frame: Day 1 (at screening)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.