AI algorithm for diagnosing Sjogren's Syndrome using salivary gland biopsy samples
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
This study is testing a new AI tool that looks at saliva gland biopsy samples to see if it can help doctors diagnose Sjogren's Syndrome more accurately.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06437652 on ClinicalTrials.gov |
What this trial studies
This research aims to develop an artificial intelligence algorithm to analyze lymphocyte focus scores in whole slide images of labial minor salivary gland biopsy samples for diagnosing Sjogren's Syndrome. The study will collect and digitize biopsy samples, which will be interpreted by experienced pathologists to establish a ground truth for the AI algorithm. The algorithm's performance will be validated through internal testing and clinical validation across multiple centers, enhancing the accuracy of diagnoses for patients suspected of having Sjogren's Syndrome.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with suspected Sjogren's Syndrome who have labial gland biopsy samples available for analysis.
Not a fit: Patients whose biopsy samples are of poor quality or do not meet the study's inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this AI algorithm could significantly improve the accuracy of diagnosing Sjogren's Syndrome, leading to better patient outcomes.
How similar studies have performed: Other studies utilizing AI for diagnostic purposes in pathology have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Ying-Qian Mo — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Ying-Qian Mo, Dr.
- Email: moyingq@mail.sysu.edu.cn
- Phone: 00861356497192
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.