Primary Sjögren's Syndrome (pSS)NCT06982482
Artificial Intelligence Based Models for Primary Sjögren's Syndrome Diagnosis
An observational study of Primary Sjögren's Syndrome (pSS), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Primary Sjögren's Syndrome (pSS)
- How many people
- 27,432 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2013to 1 Jan 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study includes patients with primary Sjögren's syndrome (pSS; diagnosed via 2016 ACR/EULAR or 2002 ACEG criteria: oral/ocular dryness, anti-SSA/Ro+, or positive biopsy) and controls (non-pSS autoimmune diseases or non-autoimmune sicca symptoms). Eligible participants were newly diagnosed at participating hospitals with complete lab data. Exclusions: pregnancy/breastfeeding, other autoimmune diseases, malignancies, severe infections, or missing lab records. Retrospective data spans multicenter clinical records, ensuring real-world validity.
Who may be able to join
- Patients with clinician-diagnosed primary Sjögren's syndrome (pSS) meeting the 2016 ACR/EULAR or 2002 ACEG classification criteria (objective oral/ocular dryness, positive anti-SSA/Ro antibodies, or focal lymphocytic sialadenitis on biopsy).
- Control groups: Individuals with non-pSS autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) or non-autoimmune conditions (e.g., dry eye/sicca symptoms without systemic autoimmunity).
Who cannot join
- Pregnancy, breastfeeding, with a clear diagnosis of other autoimmune diseases, severe infection and malignant tumors.
- Not newly diagnosed in any of the hospitals.
- Without any available laboratory tests.
Trial locations and contacts
1 site in 1 country.
China1 site
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
Nanjing, Jiangsu, 210008
About this study
Official title: Artificial Intelligence Based Models for Primary Sjögren's Syndrome Diagnosis Using Laboratory Data: A Chinese Multicenter Retrospective Study
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)
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of AI Models for Primary Sjögren's Syndrome (pSS)
The primary outcome measure is the comparative diagnostic accuracy of the AI-driven model versus the 2016 ACR/EULAR classification criteria for PSS. Accuracy will be quantified using sensitivity (true positive rate), specificity (true negative rate), and area under the receiver operating characteristic curve (AUC-ROC). The AI model's performance will be validated against a gold-standard clinician diagnosis based on comprehensive clinical, serological, and histological assessments.
Measured: Data Collection Period: January 1, 2013, to January 31, 2023 (retrospective analysis of historical records). Model Development and Validation: Completed within 12 months of data aggregation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jan 2013
- Primary completion1 Jan 2023
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Sjögren's Syndrome (pSS)Studies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 27,432 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinran Yuan, MD, Study chair, Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982482
- Sponsor's protocol ID
- B2022-529-04
- Status last verified
- Mar 2025
- First submitted
- 13 May 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu S, Wu G, Pan M, Sun Q, Gao C, Long X, Tang C, Yuan X, Sun L. A multi-criterion feature integration framework for accurate diagnosis of Sjogren's disease using routine laboratory tests. NPJ Digit Med. 2025 Nov 27;8(1):729. doi: 10.1038/s41746-025-02110-2.
PubMed 41310216
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Based Models for Primary Sjögren's Syndrome Diagnosis Using Laboratory Data: A Chinese Multicenter Retrospective Study
- ClinicalTrials.gov ID
- NCT06982482
- Acronym / sponsor ID
- B2022-529-04
- Conditions
- Primary Sjögren's Syndrome (pSS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27,432 participants (actual)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 21 May 2025 (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 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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study includes patients with primary Sjögren's syndrome (pSS; diagnosed via 2016 ACR/EULAR or 2002 ACEG criteria: oral/ocular dryness, anti-SSA/Ro+, or positive biopsy) and controls (non-pSS autoimmune diseases or non-autoimmune sicca symptoms). Eligible participants were newly diagnosed at participating hospitals with complete lab data. Exclusions: pregnancy/breastfeeding, other autoimmune diseases, malignancies, severe infections, or missing lab records. Retrospective data spans multicenter clinical records, ensuring real-world validity.
Key inclusion criteria (2 listed)
- Patients with clinician-diagnosed primary Sjögren's syndrome (pSS) meeting the 2016 ACR/EULAR or 2002 ACEG classification criteria (objective oral/ocular dryness, positive anti-SSA/Ro antibodies, or focal lymphocytic sialadenitis on biopsy).
- Control groups: Individuals with non-pSS autoimmune diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus) or non-autoimmune conditions (e.g., dry eye/sicca symptoms without systemic autoimmunity).
Key exclusion criteria (3 listed)
- Pregnancy, breastfeeding, with a clear diagnosis of other autoimmune diseases, severe infection and malignant tumors.
- Not newly diagnosed in any of the hospitals.
- Without any available laboratory tests.
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
Diagnostic Accuracy of AI Models for Primary Sjögren's Syndrome (pSS)
Time frame: Data Collection Period: January 1, 2013, to January 31, 2023 (retrospective analysis of historical records). Model Development and Validation: Completed within 12 months of data aggregation.
The primary outcome measure is the comparative diagnostic accuracy of the AI-driven model versus the 2016 ACR/EULAR classification criteria for PSS. Accuracy will be quantified using sensitivity (true positive rate), specificity (true negative rate), and area under the receiver operating characteristic curve (AUC-ROC). The AI model's performance will be validated against a gold-standard clinician diagnosis based on comprehensive clinical, serological, and histological assessments.
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 21 May 2025.
- Derived from this study: PubMed 41310216Liu S, Wu G, Pan M, Sun Q, Gao C, Long X, Tang C, Yuan X, Sun L. A multi-criterion feature integration framework for accurate diagnosis of Sjogren's disease using routine laboratory tests. NPJ Digit Med. 2025 Nov 27;8(1):729. doi: 10.1038/s41746-025-02110-2.
- Individual participant dataSharing planned: No
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.
Xinran Yuan, MD study chair
Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University
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 Primary Sjögren's Syndrome (pSS), run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 2 inclusion and 3 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 21 May 2025. 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?
Diagnostic Accuracy of AI Models for Primary Sjögren's Syndrome (pSS) (time frame: Data Collection Period: January 1, 2013, to January 31, 2023 (retrospective analysis of historical records). Model Development and Validation: Completed within 12 months of data aggregation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06982482, which also lists 1 linked publication.
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 21 May 2025.