Sclerosis, SystemicNCT07836361
Clinical Cohort Study of Systemic Sclerosis
An observational study of Sclerosis, Systemic, run by Peking University Third Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Sclerosis, Systemic
- How many people
- 150 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 31 Dec 2040
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 100 years
- All sexes
- Child, Adult, Older adult
Study population: patients with systemic sclerosis
Who may be able to join
- Patients who meet the 1980 or 2013 systemic sclerosis classification criteria
- Have signed informed consent.
Who cannot join
- More than 90% of data missing
- Patients without conditions for follow-up
- Patients who do not agree to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing
Xiaoying Zhang, 86+13810001444, zhang_xiaoying@pku.edu.cn
Xiaoying Zhang
About this study
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
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SSC | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (2)
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
Measured: 6 month
antibodies
SSc-associated antibodies include anti-topoisomerase I (anti-Scl-70), anti-centromere, and anti-RNA polymerase III antibodies.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Jan 2022
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sclerosis, SystemicStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mu Rong, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07836361
- Sponsor's protocol ID
- D2022122
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Cohort Study of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07836361
- Acronym / sponsor ID
- D2022122
- Conditions
- Sclerosis, Systemic
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SSC | – | – |
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with systemic sclerosis
Key inclusion criteria (2 listed)
- Patients who meet the 1980 or 2013 systemic sclerosis classification criteria
- Have signed informed consent.
Key exclusion criteria (3 listed)
- More than 90% of data missing
- Patients without conditions for follow-up
- Patients who do not agree to participate in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
ILD
Time frame: 6 month
antibodies
Time frame: 6 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sclerosis, Systemic, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoying Zhang (86+13810001444, zhang_xiaoying@pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mRSS (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026; AzTrials last refreshed its copy on 2 Nov 2026.