Sjögren's Diseasecell-free RNANCT07824440
a Salivary Cell-free RNA Liquid Biopsy Model for Non-invasive Diagnosis in Sjögren's Disease
An observational study of Sjögren's Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
The goal of this observational study is to learn whether salivary cell-free RNA (cfRNA) can be used as a non-invasive liquid biopsy test to help diagnose Sjögren's disease (SjD) and understand disease-related changes in the salivary glands. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sjögren's Disease
- How many people
- 101 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 30 Jun 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210008, China.
Nanjing, Jiangsu, 210008
About this study
Official title: SjoTrace-cfRNA: a Salivary Cell-free RNA Liquid Biopsy Model for Non-invasive Diagnosis and Tissue-source Tracing in Sjögren's Disease
The goal of this observational study is to learn whether salivary cell-free RNA (cfRNA) can be used as a non-invasive liquid biopsy test to help diagnose Sjögren's disease (SjD) and understand disease-related changes in the salivary glands. The main questions it aims to answer are:
- Can salivary cfRNA distinguish patients with SjD from people with sicca symptoms who do not have SjD?
- Are salivary cfRNA signals associated with clinical features of SjD, such as autoantibody-related immune activity and salivary gland pathology?
- Can salivary cfRNA signals be linked to specific cell types and tissue regions in the salivary glands? Participants will provide saliva samples, and clinical information from routine medical evaluation will be collected. Some available salivary gland tissue transcriptomic data will also be analyzed to explore the possible tissue sources of salivary cfRNA signals.
Read the detailed description
This observational study will evaluate SjoTrace, a salivary cell-free RNA (cfRNA)-based liquid biopsy approach for Sjögren's disease (SjD). SjD is an autoimmune disease that often affects the salivary glands and causes dryness symptoms, but diagnosis can be challenging because sicca symptoms may also occur in people without SjD.
In this study, saliva samples will be collected from participants with SjD and from non-SjD sicca control participants as part of an observational research protocol. Salivary cfRNA profiles will be analyzed to identify RNA features associated with SjD. Machine-learning methods will be used to develop and evaluate a cfRNA-based diagnostic score.
The study will also explore whether salivary cfRNA signals are related to clinical features of SjD, including immune-related laboratory findings and salivary gland pathology. In addition, transcriptomic datasets from salivary gland tissue, including bulk RNA sequencing, single-cell RNA sequencing, and spatial transcriptomic data, will be analyzed to investigate the possible tissue and cellular sources of disease-associated cfRNA signals.
This study does not assign participants to any treatment or intervention. All clinical care decisions will be made by the participants' regular health care providers. The research is intended to assess the diagnostic and biological value of salivary cfRNA as a non-invasive tool for SjD evaluation.
- Conditions
- Sjögren's Disease
- Medical subject headings
- Sjogren's Syndrome
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 |
|---|---|---|
| SjD Participants | Participants will include individuals diagnosed with Sjögren's disease (SjD) | |
| Non-SjD Sicca Participants | individuals with sicca symptoms who do not meet diagnostic criteria for SjD |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of model
The primary endpoint is the area under the receiver operating characteristic curve (AUC) of SjDTrace in the independent validation cohort.
Measured: half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start1 Jan 2026
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren's DiseaseStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- 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
- 101 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07824440
- Sponsor's protocol ID
- 2026-0952-01
- Acronym
- cell-free RNA
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SjoTrace-cfRNA: a Salivary Cell-free RNA Liquid Biopsy Model for Non-invasive Diagnosis and Tissue-source Tracing in Sjögren's Disease
- ClinicalTrials.gov ID
- NCT07824440
- Acronym / sponsor ID
- cell-free RNA / 2026-0952-01
- Conditions
- Sjögren's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 17 Sep 2026 (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 learn whether salivary cell-free RNA (cfRNA) can be used as a non-invasive liquid biopsy test to help diagnose Sjögren's disease (SjD) and understand disease-related changes in the salivary glands. The main questions it aims to answer are:
- Can salivary cfRNA distinguish patients with SjD from people with sicca symptoms who do not have SjD?
- Are salivary cfRNA signals associated with clinical features of SjD, such as autoantibody-related immune activity and salivary gland pathology?
- Can salivary cfRNA signals be linked to specific cell types and tissue regions in the salivary glands? Participants will provide saliva samples, and clinical information from routine medical evaluation will be collected. Some available salivary gland tissue transcriptomic data will also be analyzed to explore the possible tissue sources of salivary cfRNA signals.
Detailed description
This observational study will evaluate SjoTrace, a salivary cell-free RNA (cfRNA)-based liquid biopsy approach for Sjögren's disease (SjD). SjD is an autoimmune disease that often affects the salivary glands and causes dryness symptoms, but diagnosis can be challenging because sicca symptoms may also occur in people without SjD.
In this study, saliva samples will be collected from participants with SjD and from non-SjD sicca control participants as part of an observational research protocol. Salivary cfRNA profiles will be analyzed to identify RNA features associated with SjD. Machine-learning methods will be used to develop and evaluate a cfRNA-based diagnostic score.
The study will also explore whether salivary cfRNA signals are related to clinical features of SjD, including immune-related laboratory findings and salivary gland pathology. In addition, transcriptomic datasets from salivary gland tissue, including bulk RNA sequencing, single-cell RNA sequencing, and spatial transcriptomic data, will be analyzed to investigate the possible tissue and cellular sources of disease-associated cfRNA signals.
This study does not assign participants to any treatment or intervention. All clinical care decisions will be made by the participants' regular health care providers. The research is intended to assess the diagnostic and biological value of salivary cfRNA as a non-invasive tool for SjD evaluation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SjD Participants | – | –Participants will include individuals diagnosed with Sjögren's disease (SjD) |
| Non-SjD Sicca Participants | – | –individuals with sicca symptoms who do not meet diagnostic criteria for SjD |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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
AUC of model
Time frame: half a year
The primary endpoint is the area under the receiver operating characteristic curve (AUC) of SjDTrace in the independent validation cohort.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Sjögren's Disease, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 13 inclusion and 8 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: finished, as of the sponsor's last update on 17 Sep 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC of model (time frame: half a year). 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 Sep 2026.