NCT07824440Completed
a Salivary Cell-free RNA Liquid Biopsy Model for Non-invasive Diagnosis in Sjögren's Disease
SjoTrace-cfRNA: a Salivary Cell-free RNA Liquid Biopsy Model for Non-invasive Diagnosis and Tissue-source Tracing in Sjögren's Disease
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 101 (actual)
- First submitted
- 7 Sept 2026
- Start date
- 1 Jan 2026
- Primary completion date
- 30 Jun 2026
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Diseases
- Sjögren's disease
- NCT number
- NCT07824440
What you commit to
- Study type: Observational
- Participants enrolled: 101
- From 1 Jan 2026 to the primary completion date, 30 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
- Failure to meet the standardized oral status, fasting, or sampling timing requirements prior to collection, with resampling being impossible
Other illness
- Malignant tumors or severe active infections
- Severe hepatic or renal impairment, or other diseases that significantly interfere with cfRNA detection
- Any other conditions deemed unsuitable for participation by the investigator
Other
- Pregnancy or lactation
- Incomplete clinical data
- Substandard collection, preservation, or quality control of saliva or labial gland tissue samples
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210008, China. Coordinator of this site? Confirm its status | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.