An observational study in Sclerosis, Systemic, sponsored by Peking University Third Hospital. Recruiting at 1 site in China. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Peking University Third Hospital · Observational
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.
610 studies on the registry are indexed under Scleroderma, Systemic; 218 are open to participants now.
This study's planned enrollment of 150 is above the median of 100 across 145 observational studies indexed under Scleroderma, Systemic.
Browse Scleroderma, Systemic studies →Peking University Third Hospital is the lead sponsor of 752 studies on the registry; 273 are open to participants now.
Counted across the registry records on this site, refreshed daily.
patients with systemic sclerosis
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
antibodies
SSc-associated antibodies include anti-topoisomerase I (anti-Scl-70), anti-centromere, and anti-RNA polymerase III antibodies.
Time frame: 6 month
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Dec 2040, 227 months after the start.
Of 59 non-industry observational studies under Scleroderma, Systemic, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 80. This study's planned 227 months is above that.
Counting every sponsor, half of 61 studies reached it within 44 months; a quarter within 15 and three quarters within 80.
How these figures are worked out, and which studies are left out of them.
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