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Recruiting NCT06528197

Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese and Western Medicine

Observational Primary Sjögren Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Primary Sjögren Syndrome. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Construction of Clinical Model of Primary Sjogren's Syndrome Combined Traditional Chinese Medicine and Western Medicine Based on Multi-omics

Overview

This study aims to establish a large sample cohort of patients with primary sjogren's syndrome, collect multi-omics information of patients with primary sjogren's syndrome, and construct disease diagnosis model and disease prognosis prediction model.

Primary outcome measures

  • Number of participants with system involvement [Time frame: Baseline , 6 months follow-up]
Secondary outcome measures (3)
  • Mortality [Time frame: Baseline , 6 months follow-up]
  • Number of participants with tumor [Time frame: Baseline , 6 months follow-up]
  • Number of participants with connective tissue disease [Time frame: Baseline , 6 months follow-up]

Eligibility criteria

Inclusion criteria

  • Meets the 2002 AECG or 2016 ACR/EULAR classification criteria of primary Sjögren's syndrome.

Exclusion criteria

  • Comorbid connective tissue disease other than the disease under research.
  • Women who are pregnant or breastfeeding.
  • Combined severe cardiovascular or cerebrovascular disease, hepatic or renal failure, or severe malignant tumors.
  • Other conditions (e.g., cognitive impairment) that the investigators consider ineligible for enrollment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Jiaqi Chen — Beijing

Publications

  • Lei C, Zhang X, Zhang Y, Fang Y, Chen J, Liu Z, Zhou X, Tang B, Liao J, Huang Z, Yang J, Wang Z, Liu T, Tao Q, Luo J. Sex differences in primary Sjogren's disease: prognostic impact on mortality and cancer. Biol Sex Differ. 2026 Jan 14;17(1):25. doi: 10.1186/s13293-026-00827-7. PMID 41530868

Identifiers

NCT: NCT06528197 · 2024-1-4065

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗