NCT06982482

Artificial Intelligence Based Models for Primary Sjögren's Syndrome Diagnosis

Artificial Intelligence Based Models for Primary Sjögren's Syndrome Diagnosis Using Laboratory Data: A Chinese Multicenter Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 27,432 (actual)
• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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 data. The main question it aims to answer is: Can AI-based algorithms accurately diagnose Primary Sjögren's Syndrome by analyzing laboratory test results, and do they outperform traditional diagnostic criteria in Chinese populations? Researchers will retrospectively analyze anonymized clinical records and laboratory data (e.g., autoantibody levels, inflammatory markers) from patients with suspected or confirmed PSS across multiple medical centers in China. No new interventions will be administered, as the study utilizes existing historical data to train and validate the AI models. The performance of AI algorithms will be compared with current diagnostic standards (e.g., ACR/EULAR criteria) in terms of sensitivity, specificity, and clinical utility.

Conditions

• Primary Sjögren's Syndrome (pSS)

Timeline

• Start date: 2013-01-01
• Primary completion: 2023-01-01
• Completion: 2025-01-01
• First posted: 2025-05-21
• Last updated: 2025-05-21

Locations

1 site across 1 country: China