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

NCT06528197 | Recruiting

• 1 other identifier: 2024-1-4065
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Sjögren Syndrome

Outcome Measures

Primary Outcomes (1)

• Number of participants with system involvement

  System involvement determined from clinical diagnosis

  Baseline , 6 months follow-up

Secondary Outcomes (3)

• Mortality

  Baseline , 6 months follow-up

• Number of participants with tumor

  Baseline , 6 months follow-up

• Number of participants with connective tissue disease

  Baseline , 6 months follow-up

Study Arms (2)

Exposed group

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary Sjögren's syndrome

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead
• Xiyuan Hospital of China Academy of Chinese Medical Sciences: collaborator
• Beijing Hospital of Traditional Chinese Medicine: collaborator
• Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital: collaborator

Study Sites (1)

Jiaqi Chen

Beijing, Beijing Municipality, 100029, China

RECRUITING

Related Publications (1)

• 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. doi: 10.1186/s13293-026-00827-7. Online ahead of print.

  PMID: 41530868 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: July 30, 2024
• Study Start: July 4, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)