a Salivary Cell-free RNA Liquid Biopsy Model for Non-invasive Diagnosis in Sjögren's Disease

NCT07824440 | Completed DMC

• 1 other identifier: 2026-0952-01
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sjögren's Disease

Outcome Measures

Primary Outcomes (1)

• AUC of model

  The primary endpoint is the area under the receiver operating characteristic curve (AUC) of SjDTrace in the independent validation cohort.

  half a year

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University, Nanjing, 210008, China.

Nanjing, Jiangsu, 210008, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva samples will be collected and retained for cell-free RNA extraction and transcriptomic analysis. When available, residual or research-use salivary gland tissue specimens, including minor salivary gland biopsy samples or derived transcriptomic data, may be retained or analyzed for bulk RNA sequencing, single-cell RNA sequencing, spatial transcriptomic analysis, and related biomarker validation studies. Clinical data associated with these biospecimens may be retained in de-identified form for correlation with molecular findings.

MeSH Terms

Conditions

Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Dry Eye Syndromes; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 17, 2026
• Study Start: January 1, 2026
• Primary Completion: June 30, 2026
• Study Completion: June 30, 2026
• Last Updated: September 17, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)