RecruitingNCT06437652

An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome

An Artificial Intelligence Algorithm for Lymphocyte Focus Score in Whole Slide Images of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome : a Blinded Clinical Validation and Deployment Study

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

1,000 participants

Start Date

Oct 1, 2023

Study Type

OBSERVATIONAL

Conditions

Sjogren's Syndrome

Summary

The aim of this research is to discover an artificial intelligence (AI) algorithm for lymphocyte focus score in whole slide images of labial minor salivary gland (SG) biopsy samples for diagnosing Sjogren's Syndrome, in order to enhance the precision of pathological interpretation of labial minor SG biopsy samples in patients with suspected Sjogren's syndrome and aid clinicians make an accurate diagnose. A remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG will be built for the global based on the research results. The research will propose the AI-assisted pathological interpretation of lymphocyte focus score in labial minor SG biopsy samples in the future guidelines for the diagnosis and treatment of Sjogren's syndrome. The research will： 1. Develop and debug the AI algorithm for lymphocyte focus score in whole slide images of labial minor SG biopsy samples for diagnosing Sjogren's Syndrome; 2. Internal test of the AI algorithm; 3. Clinical validation of the AI algorithm with blind method in multiple centers; 4）Built a remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG for the global and Explore its clinical application.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study uses an artificial intelligence (AI) algorithm to analyze microscope images of small salivary gland biopsies to help diagnose Sjögren's Syndrome — an autoimmune disease where the immune system attacks moisture-producing glands, causing dry eyes and dry mouth. The AI scores how many immune cells are clustered in the gland tissue, which is a key diagnostic marker. **You may be eligible if...** - You are a patient with suspected Sjögren's Syndrome who has had a lip (labial) salivary gland biopsy - Your biopsy slides have been digitized and can be uploaded to the study platform **You may NOT be eligible if...** - Your biopsy sections are too thick, causing overlapping cells - The tissue sample is incomplete or the staining quality is poor - No salivary gland tissue is visible in the sample - The image quality is not clear enough for analysis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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