跳至主要内容
临床试验/NCT07836361
NCT07836361招募中不适用

Clinical Cohort Study of Systemic Sclerosis

Peking University Third Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
mRSS

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

SSC

结局指标

主要结局

mRSS

时间窗: 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.

次要结局

  • ILD(6 month)
  • antibodies(6 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mu Rong

Prof.

Peking University Third Hospital

研究点 (1)

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