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Immune mechanisms of salivary gland injury in primary Sjögren's syndrome

A preliminary exploration of the immune microenvironment in the salivary glands of primary Sjögren's syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097544
Enrollment
Unknown
Registered
2025-02-20
Start date
2025-01-03
Completion date
Unknown
Last updated
2025-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Sjögren's syndrome

Interventions

Primary sjogren's syndrome group:None
Control group:None

Sponsors

The Third Affiliated Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Patients who meet the 2016 United States College of Rheumatology/European League Against Rheumatism classification criteria for PSS. Specifically: (1) labial focal lymphocytic infiltration with a focal index >= 1 lesion/4 mm^2 (should be scored by a pathologist who specializes in focal lymphocyte infiltration and focal index counting), 3 points; (2) Positive anti-SSA/Ro antibody, 3 points; (3) At least 1 point for monocular OSS staining score >=5 or van Bijsterveld score >=4); (4) At least monocular Schirmer test =4 was diagnosed as pSS. 2. Be between the ages of 18-70; 3.Without other well-diagnosed diseases, such as diabetes, cardiovascular disease, autoimmune disease, or viral infection; 4.No recent history of vaccination, surgery, organ transplantation, and chemoradiotherapy; 5.Subjects in the control group should meet the following criteria: 1) have dry mouth symptoms; 2) Pre-healthy, no benign and malignant tumors, endocrine diseases, cardiovascular diseases and autoimmune diseases; 3) No recent history of infection, vaccination, radiation exposure and drug use;4)Be between the ages of 18-70.

Exclusion criteria

Exclusion criteria: 1.Age70; 2.Pregnant or lactating; 3.Comorbid with the following conditions: history of head and neck radiotherapy, active hepatitis C virus infection (confirmed by PCR), AIDS, sarcoidosis, amyloidosis, graft-versus-host disease, autoimmune diseases such as IgG4-related disease, and systemic lupus erythematosus; 4.Recent vaccination, surgery, organ transplant, or receiving medication or chemoradiotherapy.

Design outcomes

Primary

MeasureTime frame
sjogren's syndrome disease activity index;

Secondary

MeasureTime frame
total saliva flow rate;Schirmer test;break-up time;

Countries

China

Contacts

Public ContactLu Chenyang

The Third Affiliated Hospital Sun Yat-sen University

1301653217@qq.com+86 13602478696

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026