Clinical Cohort Study of Systemic Sclerosis

NCT07836361 | Recruiting

• 1 other identifier: D2022122
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Systemic sclerosis (SSc) is an autoimmune disease primarily characterized by fibrosis of the skin and internal organs. In 2018, SSc was included in China's "First Batch of Rare Disease Catalog." Compared with the well-established large-scale SSc clinical cohorts in Europe, China's SSc cohort research is still in its infancy. Limited by the small number of SSc patients, complex and diverse clinical manifestations, uneven regional diagnostic and treatment capabilities, and dispersed research resources, there is currently a lack of in-depth research on the pathogenesis, disease characteristics, early intervention, precision treatment, and prognosis evaluation of SSc. Based on the preliminary research of the research group, this project will leverage the advantageous platforms of our hospital and SSc patient public welfare organizations to establish a scleroderma trial and research cohort, conduct clinical analysis, and screen for novel biological markers and drug targets, carry out large-scale epidemiological investigations, and cultivate specialized personnel, establish and improve China's SSc chronic disease management system, achieve balanced and equitable SSc diagnosis and treatment resources in China, and benefit the vast number of patients.

Conditions

Sclerosis, Systemic

Outcome Measures

Primary Outcomes (1)

• mRSS

  The modified Rodnan Skin Score (mRSS) is the standard, validated outcome measure for assessing the extent and severity of skin thickening (fibrosis) in systemic sclerosis (SSc)，range 0-51.

  3 months

Secondary Outcomes (2)

• ILD

  6 month

• antibodies

  6 month

Study Arms (1)

SSC

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with systemic sclerosis

You may qualify if:

• Patients who meet the 1980 or 2013 systemic sclerosis classification criteria
• Have signed informed consent.

You may not qualify if:

• More than 90% of data missing
• Patients without conditions for follow-up
• Patients who do not agree to participate in this study

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Xiaoying Zhang

CONTACT

86+13810001444; zhang_xiaoying@pku.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 23, 2026
• Study Start: January 1, 2022
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)