Sjogren's SyndromeNCT06437652
An AI Algorithm for Lymphocyte Focus Score of Minor Salivary Gland Biopsy Samples for Diagnosing Sjogren's Syndrome
An observational study of Sjogren's Syndrome, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sjogren's Syndrome
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2023to 30 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The suspected SjS patients presenting with ocular dryness and/or oral dryness, as determined by the American-European Consensus Group (AECG) questions
Who may be able to join
- The original format of digital pathological images of labial gland biopsy tissue from patients with suspected Sjögren's Syndrome uploaded to the designated platform.
Who cannot join
- Overlapping layers of cells due to excessively thick sections;
- Excessive tissue defects caused by incomplete sectioning or poor staining on slides;
- Absence of labial gland;
- Insufficient clarity in the image.
Trial locations and contacts
1 site in 1 country.
About this study
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：
- 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;
- Internal test of the AI algorithm;
- 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.
Read the detailed description
- 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; A total of 200 H\&E staining slides of labial minor SG biopsy samples are collected from Sun Yat-sen Memorial Hospital of Sun Yat-sen University and scanned into digital pathological images. The ground truth of gland tissue area and lymphocyte foci numbers in each image is interpreted by three senior pathologists with over 5 years of related experience.
- Internal test of the AI algorithm; A total of 500 additional digital pathological images of labial gland biopsy tissues are collected from Sun Yat-sen Memorial Hospital of Sun Yat-sen University. The ground truth of gland tissue area and lymphocyte foci numbers in each images is interpreted by three senior pathologists with over 5 years of related experience. The AI algorithm's accuracy, specificity, sensitivity, positive predictive value and negative predictive value in evaluating the area of labial gland and the number of lymphocyte foci are calculated. Comparison of whether the image meets the criteria for Sjögren's syndrome (focus score greater than 1) is also conducted between the AI algorithm and the ground truth.
- Clinical validation of the AI algorithm with blind method in multiple centers; A total of 600 additional digital pathological images of labial gland biopsy tissues are collected from six external centers. The ground truth of gland tissue area and lymphocyte foci numbers in each images is interpreted by three senior pathologists with over 5 years of related experience. The AI algorithm's accuracy, specificity, sensitivity, positive predictive value and negative predictive value in evaluating the area of labial gland and the number of lymphocyte foci are calculated. Comparison of whether the image meets the criteria for Sjögren's syndrome (focus score greater than 1) is also conducted between the AI algorithm and the ground truth.
4）Built a remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG for the global and Explore its clinical application.
Digital pathological images of labial gland biopsy tissue can be uploaded to the Labial Gland Pathological Focus Score Remoting platform. AI-assisted pathological interpretation on gland tissue area, lymphocyte foci numbers, and whether meeting the criteria for Sjögren's syndrome (focus score greater than 1) is compared with the ground truth.
- Conditions
- Sjogren's Syndrome
- Medical subject headings
- Sjogren's Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the procedure
Secondary outcomes (1)
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.
Measured: during the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2024
- Study start1 Oct 2023
- Primary completion30 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moyingqian, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06437652
- Sponsor's protocol ID
- SYSKY-2023-915-01
- Status last verified
- Apr 2026
- First submitted
- 11 May 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06437652
- Acronym / sponsor ID
- SYSKY-2023-915-01
- Conditions
- Sjogren's Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 31 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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：
- 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;
- Internal test of the AI algorithm;
- 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.
Detailed description
- 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; A total of 200 H\&E staining slides of labial minor SG biopsy samples are collected from Sun Yat-sen Memorial Hospital of Sun Yat-sen University and scanned into digital pathological images. The ground truth of gland tissue area and lymphocyte foci numbers in each image is interpreted by three senior pathologists with over 5 years of related experience.
- Internal test of the AI algorithm; A total of 500 additional digital pathological images of labial gland biopsy tissues are collected from Sun Yat-sen Memorial Hospital of Sun Yat-sen University. The ground truth of gland tissue area and lymphocyte foci numbers in each images is interpreted by three senior pathologists with over 5 years of related experience. The AI algorithm's accuracy, specificity, sensitivity, positive predictive value and negative predictive value in evaluating the area of labial gland and the number of lymphocyte foci are calculated. Comparison of whether the image meets the criteria for Sjögren's syndrome (focus score greater than 1) is also conducted between the AI algorithm and the ground truth.
- Clinical validation of the AI algorithm with blind method in multiple centers; A total of 600 additional digital pathological images of labial gland biopsy tissues are collected from six external centers. The ground truth of gland tissue area and lymphocyte foci numbers in each images is interpreted by three senior pathologists with over 5 years of related experience. The AI algorithm's accuracy, specificity, sensitivity, positive predictive value and negative predictive value in evaluating the area of labial gland and the number of lymphocyte foci are calculated. Comparison of whether the image meets the criteria for Sjögren's syndrome (focus score greater than 1) is also conducted between the AI algorithm and the ground truth.
4）Built a remote AI-assisted pathological interpretation platform for lymphocyte focus score in labial SG for the global and Explore its clinical application.
Digital pathological images of labial gland biopsy tissue can be uploaded to the Labial Gland Pathological Focus Score Remoting platform. AI-assisted pathological interpretation on gland tissue area, lymphocyte foci numbers, and whether meeting the criteria for Sjögren's syndrome (focus score greater than 1) is compared with the ground truth.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The suspected SjS patients presenting with ocular dryness and/or oral dryness, as determined by the American-European Consensus Group (AECG) questions
Key inclusion criteria (1 listed)
- The original format of digital pathological images of labial gland biopsy tissue from patients with suspected Sjögren's Syndrome uploaded to the designated platform.
Key exclusion criteria (4 listed)
- Overlapping layers of cells due to excessively thick sections;
- Excessive tissue defects caused by incomplete sectioning or poor staining on slides;
- Absence of labial gland;
- Insufficient clarity in the image.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The accuracy of pathological interpretation of focal index of labial gland tissue
Time frame: during the procedure
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.
1 secondary outcome
The precision of pathological interpretation regarding the area of glandular tissue and the count of lymphocyte foci in labial gland tissue.
Time frame: during the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjogren's Syndrome, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of pathological interpretation of focal index of labial gland tissue (time frame: during the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.