Sjogren's Syndrome Clinical Trial
Official title:
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
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.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: - The original format of digital pathological images of labial gland biopsy tissue from patients with suspected Sjögren's Syndrome uploaded to the designated platform. Exclusion Criteria: 1. Overlapping layers of cells due to excessively thick sections; 2. Excessive tissue defects caused by incomplete sectioning or poor staining on slides; 3. Absence of labial gland; 4. Insufficient clarity in the image. |
Country | Name | City | State |
---|---|---|---|
China | Ying-Qian Mo | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The accuracy of pathological interpretation of focal index of labial gland tissue | The ground truth of gland tissue area and lymphocyte foci numbers in consecutive images is interpreted by three senior pathologists with over 5 years of related experience. The focal score is determined by the gland tissue area and the number of lymphocyte foci. AI-assisted interpretation is compared with ground truth. | during the procedure | |
Secondary | The precision of pathological interpretation regarding the area of glandular tissue and the count of lymphocyte foci in labial gland tissue. | AI-assisted interpretation is compared with ground truth. | during the procedure |
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