Healthy AdultNCT07168122
Establishment and Clinical Application of Reference Intervals of Salivary Cortisol
An observational study of Healthy Adult and Cushing Syndrome, run by Shanghai 6th People's Hospital at 1 site in China.
Trial summary
The goal of this observational study is to establish the normal reference intervals of salivary cortisol and optimal cut-offs for Cushing's sydrome and adrenal insufficiency. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult, Cushing Syndrome, Adrenal Insufficiency
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The participants are enrolled from Shanghai Sixth People's Hospital, Shanghai.
Who may be able to join
- Age ≥ 18 and ≤ 60 years old;
- Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg*m^-2;
- No previous history of chronic diseases such as hyperglycemia, hypertension, dyslipidemia, coronary heart disease and stroke;
- Normal glucose regulation, defined as: fasting blood-glucose < 5.6 mmol/L, 2-hour blood-glucose after glucose load < 7.8 mmol/L, and glycated hemoglobin (HbA1c) < 5.7%.
- Aged 18 to 80 years old;
- Patients with suspected Cushing's syndrome or adrenal insufficiency.
Who cannot join
- Liver or kidney dysfunction, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or direct bilirubin higher than 1.5 times the upper limit of normal, or serum creatinine >115 μmol/L;
- Pregnancy or lactation women, or people with cancer or mental illness;
- Factors affecting cortisol levels, including hypothalamus-pituitary-adrenal axis disease, autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, etc.), diagnosed mental disease, Alzheimer's disease, alcoholism (alcohol > 60 g/d for male, >40 g/d for women) and corticosteroid therapy in the past 3 months (females with contraceptives or estrogen);
- Factors affecting saliva collection, such as serious oral problems (oral ulcers, gingival bleeding);
- Night shift workers, who are awake from 11:00 PM to 7:00 AM;
- Acute infection (body temperature ≥ 37.3 ℃ or C-reactive protein > 50 mg/L).
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- Cases:
- Corticosteroid therapy within the last 6 weeks;
- Acute infection;
- Severe oral conditions;
- Severe liver and kidney dysfunction;
- Alcoholism, depression, or other psychiatric disorders.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Yufei Zhou, B.S., 16621727469, zyf2020@sjtu.edu.cn
About this study
Official title: Study for Reference Intervals and Optimal Cut-offs for Salivary Cortisol
The goal of this observational study is to establish the normal reference intervals of salivary cortisol and optimal cut-offs for Cushing's sydrome and adrenal insufficiency.
Read the detailed description
Saliva testing is a non-invasive alternative to blood tests for measuring cortisol, a key hormone for assessing endocrine status and diagnosing conditions like Cushing's syndrome. It accurately reflects physiologically active free cortisol. However, its clinical use is hampered by extremely low cortisol concentrations and the lack of reliable detection methods. We have developed two advanced technologies: an immunomagnetic-bead-based LC-MS assay with simplified preparation, and a fluorescence immunoassay system for point-of-care testing. To promote their clinical adoption, this study will establish normal reference intervals of salivary cortisol for both methods in a healthy population and optimal cut-offs in cases of Cushing's sydrome and adrenal insufficiency.
- Conditions
- Healthy Adult, Cushing Syndrome, Adrenal Insufficiency
- Medical subject headings
- Cushing Syndrome, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heathy Volunteers | 120 Healthy Volunteers for the establishment of reference intervals of salivary cortisol | |
| Cushing's sydrome | 50 cases diagnosed with Cushing's sydrome | |
| Adrenal insufficiency | 50 cases diagnosed with adrenal insufficiency |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reference intervals of salivary cortisol
Salivary cortisol levels were evaluated by immunomagnetic-bead-based LC-MS assay and fluorescence immunoassay system to establish its reference intervals according to the 2.5th and 97.5th percentiles.
Measured: 8:00, 16:00 and 23:00 on the day of sample collection
Optimal cut-off and diagnostic accuracy of salivary cortisol in Cushing's syndrome
The diagnostic cut-off for each analysis method was defined as either the calculated upper reference interval (97.5th percentile) or the optimal value determined by the Youden index. The sensitivity, specificity and area under curve for Cushing's syndrome was calculated using samples from all available healthy controls and cases.
Measured: 23:00 on the day of sample collection
Optimal cut-off and diagnostic accuracy of salivary cortisol in adrenal insufficiency
The diagnostic cut-off for each analysis method was defined as either the calculated lower reference intervals (2.5th percentile) or the optimal value determined by the Youden index. The sensitivity, specificity and area under curve for adrenal insufficiency was calculated using samples from all available healthy controls and cases.
Measured: 8:00 on the day of sample collection
Comparison of diagnostic accuracy of salivary cortisol in Cushing's syndrome and adrenal insufficiency
The diagnostic accuracies of the fluorescence immunoassay system and the immunomagnetic-bead-based LC-MS assay were compared by analyzing their areas under the receiver operating characteristic (ROC) curves using DeLong's test for paired statistics.
Measured: 8:00 or 23:00 on the day of sample collection
Secondary outcomes (4)
Agreement in assessment of salivary cortisol
To assess the agreement in assessment of salivary cortisol between immunomagnetic-bead-based LC-MS assay and fluorescence immunoassay system
Measured: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different age ranges
Comparsion of salivary cortisol levels in subgroups of age
Measured: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different sex
Comparsion of salivary cortisol levels in subgroups of sex
Measured: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different body mass index ranges
Comparsion of salivary cortisol levels in subgroups of body mass index
Measured: 8:00, 16:00 and 23:00 on the day of sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai 6th People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhou, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168122
- Sponsor's protocol ID
- 20250811
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study for Reference Intervals and Optimal Cut-offs for Salivary Cortisol
- ClinicalTrials.gov ID
- NCT07168122
- Acronym / sponsor ID
- 20250811
- Conditions
- Healthy Adult, Cushing Syndrome, Adrenal Insufficiency
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shanghai 6th People's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 11 Sep 2025 (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.
The goal of this observational study is to establish the normal reference intervals of salivary cortisol and optimal cut-offs for Cushing's sydrome and adrenal insufficiency.
Detailed description
Saliva testing is a non-invasive alternative to blood tests for measuring cortisol, a key hormone for assessing endocrine status and diagnosing conditions like Cushing's syndrome. It accurately reflects physiologically active free cortisol. However, its clinical use is hampered by extremely low cortisol concentrations and the lack of reliable detection methods. We have developed two advanced technologies: an immunomagnetic-bead-based LC-MS assay with simplified preparation, and a fluorescence immunoassay system for point-of-care testing. To promote their clinical adoption, this study will establish normal reference intervals of salivary cortisol for both methods in a healthy population and optimal cut-offs in cases of Cushing's sydrome and adrenal insufficiency.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Heathy Volunteers | – | –120 Healthy Volunteers for the establishment of reference intervals of salivary cortisol |
| Cushing's sydrome | – | –50 cases diagnosed with Cushing's sydrome |
| Adrenal insufficiency | – | –50 cases diagnosed with adrenal insufficiency |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The participants are enrolled from Shanghai Sixth People's Hospital, Shanghai.
Key inclusion criteria (6 listed)
- Age ≥ 18 and ≤ 60 years old;
- Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg*m^-2;
- No previous history of chronic diseases such as hyperglycemia, hypertension, dyslipidemia, coronary heart disease and stroke;
- Normal glucose regulation, defined as: fasting blood-glucose < 5.6 mmol/L, 2-hour blood-glucose after glucose load < 7.8 mmol/L, and glycated hemoglobin (HbA1c) < 5.7%.
- Aged 18 to 80 years old;
Key exclusion criteria (12 listed)
- Liver or kidney dysfunction, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or direct bilirubin higher than 1.5 times the upper limit of normal, or serum creatinine >115 μmol/L;
- Pregnancy or lactation women, or people with cancer or mental illness;
- Factors affecting cortisol levels, including hypothalamus-pituitary-adrenal axis disease, autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis, etc.), diagnosed mental disease, Alzheimer's disease, alcoholism (alcohol > 60 g/d for male, >40 g/d for women) and corticosteroid therapy in the past 3 months (females with contraceptives or estrogen);
- Factors affecting saliva collection, such as serious oral problems (oral ulcers, gingival bleeding);
- Night shift workers, who are awake from 11:00 PM to 7:00 AM;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reference intervals of salivary cortisol
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
Salivary cortisol levels were evaluated by immunomagnetic-bead-based LC-MS assay and fluorescence immunoassay system to establish its reference intervals according to the 2.5th and 97.5th percentiles.
Optimal cut-off and diagnostic accuracy of salivary cortisol in Cushing's syndrome
Time frame: 23:00 on the day of sample collection
The diagnostic cut-off for each analysis method was defined as either the calculated upper reference interval (97.5th percentile) or the optimal value determined by the Youden index. The sensitivity, specificity and area under curve for Cushing's syndrome was calculated using samples from all available healthy controls and cases.
Optimal cut-off and diagnostic accuracy of salivary cortisol in adrenal insufficiency
Time frame: 8:00 on the day of sample collection
The diagnostic cut-off for each analysis method was defined as either the calculated lower reference intervals (2.5th percentile) or the optimal value determined by the Youden index. The sensitivity, specificity and area under curve for adrenal insufficiency was calculated using samples from all available healthy controls and cases.
Comparison of diagnostic accuracy of salivary cortisol in Cushing's syndrome and adrenal insufficiency
Time frame: 8:00 or 23:00 on the day of sample collection
The diagnostic accuracies of the fluorescence immunoassay system and the immunomagnetic-bead-based LC-MS assay were compared by analyzing their areas under the receiver operating characteristic (ROC) curves using DeLong's test for paired statistics.
4 secondary outcomes
Agreement in assessment of salivary cortisol
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different age ranges
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different sex
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
Between-groups differences in salivary cortisol of healthy volunteers with different body mass index ranges
Time frame: 8:00, 16:00 and 23:00 on the day of sample collection
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 11 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Healthy Adult and Cushing Syndrome, run by Shanghai 6th People's Hospital at 1 site in China.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 11 Sep 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 China. 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?
Contact Jian Zhou, Doctor (+86-021-64369181, zhoujian@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reference intervals of salivary cortisol (time frame: 8:00, 16:00 and 23:00 on the day of sample collection). The study lists 4 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 11 Sep 2025.