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NCT Number: NCT07836361

Clinical Cohort Study of Systemic Sclerosis

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.

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Key information

Age range

Up to 100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking University Third Hospital

Beijing, China

Location status: Recruiting

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. mRSS

    Time frame: 3 months

    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.

Secondary outcomes

  1. ILD

    Time frame: 6 month

    Interstitial Lung Disease (ILD) in the context of systemic sclerosis (SSc), is characterized by inflammation and progressive fibrosis of the lung interstitium. Pulmonary Function Tests (PFTs) and chest High-Resolution Computed Tomography are used to detect and monitor impairment in SSc-ILD

  2. antibodies

    Time frame: 6 month

    SSc-associated antibodies include anti-topoisomerase I (anti-Scl-70), anti-centromere, and anti-RNA polymerase III antibodies.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Peking University Third Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2040
Study completion
2040
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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