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Saliva test could spot hormone disorders faster

NCT ID NCT07168122

Diagnosis Sponsor: Shanghai 6th People's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This observational study will measure salivary cortisol in 220 healthy adults and people with Cushing's syndrome or adrenal insufficiency. The goal is to establish normal reference ranges and find the best cut-off values for diagnosis. Researchers will compare two lab methods to see which works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could improve how doctors diagnose Cushing's syndrome and adrenal insufficiency using a simple saliva test.
What could go wrong
This is an early observational study, not a treatment trial. The results may not apply to all populations or settings.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The participants are enrolled from Shanghai Sixth People's Hospital, Shanghai.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Healthy Volunteers: Inclusion Criteria: 1. Age ≥ 18 and ≤ 60 years old; 2. Body mass index (BMI) ≥ 18.5 and ≤ 24.9 kg\*m\^-2; 3. No previous history of chronic diseases such as hyperglycemia, hypertension, dyslipidemia, coronary heart disease and stroke; 4. 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%. Exclusion Criteria: 1. 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; 2. Pregnancy or lactation women, or people with cancer or mental illness; 3. 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); 4. Factors affecting saliva collection, such as serious oral problems (oral ulcers, gingival bleeding); 5. Night shift workers, who are awake from 11:00 PM to 7:00 AM; 6. Acute infection (body temperature ≥ 37.3 ℃ or C-reactive protein \> 50 mg/L). Cases: Inclusion Criteria: 1. Aged 18 to 80 years old; 2. Patients with suspected Cushing's syndrome or adrenal insufficiency. Exclusion Criteria: 1. Corticosteroid therapy within the last 6 weeks; 2. Acute infection; 3. Severe oral conditions; 4. Severe liver and kidney dysfunction; 5. Alcoholism, depression, or other psychiatric disorders.

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Conditions

The condition(s) this trial relates to.

adrenocortical insufficiency Cushing syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adrenal insufficiency Cushing syndrome Healthy adult

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai Sixth People's Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200233, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.