Spit test aims to spot Sjögren's disease without a biopsy
NCT ID NCT07824440
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are studying whether cell-free RNA in saliva can work as a non-invasive liquid biopsy to help diagnose Sjögren's disease. The trial compares saliva from people with Sjögren's disease against saliva from people with dry-eye and dry-mouth symptoms who do not have the disease. Scientists also check whether the RNA signals match clinical features such as autoantibodies and salivary gland changes, and whether they can be traced back to specific cell types in the glands. About 100 adults aged 18 to 65 take part by giving saliva samples and allowing their routine clinical data to be used.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a saliva-based cell-free RNA liquid biopsy test
- What this could lead to
- If it works, this could offer a simple spit test that helps diagnose Sjögren's disease without a gland biopsy and points to which salivary tissues are involved.
- What could go wrong
- This is an early observational study of about 100 people at one hospital, so the RNA signature may not hold up in larger or more diverse groups, and it cannot yet replace standard diagnostic tests.
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
-
101 people
The number who actually took part.
- Started
-
Jan 2026
- Finished
-
Jun 2026
- 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
Patients newly or previously diagnosed with Sjögren's disease (SjD). Diagnostic Authority: Must strictly fulfill the 2016 ACR/EULAR classification criteria with complete, verifiable diagnostic evidence. Demographics: Adults aged 18 to 65 years. Compliance: Individuals willing to provide detailed clinical data, saliva samples, and written informed consent. Asymptomatic Controls (Non-SjD Sicca Control Group)Clinical Presentation: Individuals without any persistent symptoms suggestive of SjD (such as dry eyes or mouth) and whose physical and necessary laboratory findings are within normal limits. Medical History: Individuals with no personal or family history of autoimmune diseases. Demographics: Adults aged 18 to 65 years, also frequency-matched by sex and age to the SjD cohort.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
Inclusion Criteria: SjD group: * Aged 18-65 years * Fulfilled the 2016 ACR/EULAR classification criteria for Sjögren's disease * Newly diagnosed or previously diagnosed with complete diagnostic evidence available * Willing to provide clinical data and saliva samples * Provided written informed consent Non-SjD sicca control group: * Aged 18-65 years * Frequency-matched with the case group by sex and age * No personal or family history of autoimmune diseases * No persistent symptoms suggestive of SjD (e.g., dry mouth or dry eyes), with physical examination and necessary laboratory test results within normal limits * Willing to provide clinical data and saliva samples * Provided written informed consent Exclusion Criteria: * Malignant tumors or severe active infections * Pregnancy or lactation * Use of biologics or potent immunosuppressive therapy within the past 3 months that could significantly alter study indicators (patients included due to strict clinical necessity will be recorded and utilized for sensitivity analysis) * Severe hepatic or renal impairment, or other diseases that significantly interfere with cfRNA detection * Failure to meet the standardized oral status, fasting, or sampling timing requirements prior to collection, with resampling being impossible * Incomplete clinical data * Substandard collection, preservation, or quality control of saliva or labial gland tissue samples * Any other conditions deemed unsuitable for participation by the investigator
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Sjögren's disease are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210008, China.
Nanjing, Jiangsu, 210008, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can one pill tame four autoimmune diseases? a Long-Term trial puts it to the test
- Can a new drug ease the dryness, pain, and fatigue of Sjögren's disease?
- New drug HBM7020 tested in humans for first time against autoimmune diseases
- New monthly shot could ease Sjögren's dry mouth
- New eye drop battle: which offers better dry eye relief?
- New biologic XmAb657 enters first human tests for autoimmune conditions