Clinical Cohort Study of Systemic Sclerosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 100
SponsorPeking University Third Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who meet the 1980 or 2013 systemic sclerosis classification criteria

Have signed informed consent.

Disqualifiers

More than 90% of data missing

Patients without conditions for follow-up

Patients who do not agree to participate in this study

Trial population

patients with systemic sclerosis

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: SSC

Trial outcomes

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.

Time frame
3 months

Secondary outcomes

1

ILD

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

Time frame
6 month
2

antibodies

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

Time frame
6 month

Other outcomes

Sponsors and contacts

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