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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Sjögren Syndrome

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Jiaqi Chen
      • Contact: Jiaqi Chen, PhD; Phone Number: +86-010-54205067; Email: jiaqichen19@outlook.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with primary Sjögren's syndrome

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Control group
Exposed group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with system involvement	System involvement determined from clinical diagnosis	Baseline , 6 months follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	All-cause mortality	Baseline , 6 months follow-up
Number of participants with tumor	Tumor determined from clinical diagnosis	Baseline , 6 months follow-up
Number of participants with connective tissue disease	Connective tissue disease determined from clinical diagnosis	Baseline , 6 months follow-up

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Xiyuan Hospital of China Academy of Chinese Medical Sciences; Beijing Hospital of Traditional Chinese Medicine; Shunyi Hospital, Beijing Traditional Chinese Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 4, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 12, 2024
• First Submitted That Met QC Criteria: July 29, 2024
• First Posted (Actual): July 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Eye Diseases; Disease; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Syndrome; Sjogren's Syndrome
• Other Study ID Numbers: 2024-1-4065

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No