Status:
COMPLETED
Artificial Intelligence Based Models for Primary Sjögren's Syndrome Diagnosis
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Primary Sjögren's Syndrome (pSS)
Eligibility:
All Genders
18-65 years
Brief Summary
The goal of this observational study is to develop and validate artificial intelligence (AI)-driven models for improving the diagnosis of Primary Sjögren's Syndrome (PSS) using routine laboratory test...
Eligibility Criteria
Inclusion
- Patients with clinician-diagnosed primary Sjögren's syndrome (pSS) meeting the 2016 ACR/EULAR or 2002 ACEG classification criteria (objective oral/ocular dryness, positive anti-SSA/Ro antibodies, or focal lymphocytic sialadenitis on biopsy).
- Control groups: Individuals with non-pSS autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) or non-autoimmune conditions (e.g., dry eye/sicca symptoms without systemic autoimmunity).
Exclusion
- Pregnancy, breastfeeding, with a clear diagnosis of other autoimmune diseases, severe infection and malignant tumors.
- Not newly diagnosed in any of the hospitals.
- Without any available laboratory tests.
Key Trial Info
Start Date :
January 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
27432 Patients enrolled
Trial Details
Trial ID
NCT06982482
Start Date
January 1 2013
End Date
January 1 2025
Last Update
May 21 2025
Active Locations (1)
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1
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, China, 210008