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临床试验/NCT04986514
NCT04986514撤回不适用

Identification of Biomarkers Associated With Disease Worsening Within 10 Years in Scleroderma Patients

University Hospital, Lille0 个研究点目标入组 1,000 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
入组人数
1,000
主要终点
Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage

研究概览

简要总结

Systemic sclerosis (SSc) is the most severe of the systemic autoimmune diseases. It is characterized by skin and organ fibrosis (mainly interstitial lung disease, which affects 40-50% of patients), as well as severe vascular complications such as pulmonary hypertension (5-10%), renal crisis (2%), and digital gangrene (5%). There are currently no validated prognostic biomarkers for the progression of SSc, yet it is crucial to better predict the progression of SSc to optimize patient management, but also to identify the optimal population for clinical trials ("progressor" patients). Furthermore, there are no validated biomarkers of response to immunosuppressive therapies that would be useful both in patient management and in the evaluation of new treatments in clinical trials. The internal medicine department of the Lille University Hospital is a national and European reference center for the management of patients with SSc. Nearly 500 patients are followed annually in the internal medicine department. As part of their routine care, patients are hospitalized in average once a year in the internal medicine department of the Lille University Hospital for a complete assessment of their SSc. This assessment includes a detailed medical observation, complementary examinations and blood and urine biology tests. The purpose of this study would be to collect 2 additional blood samples during the standard evaluation of scleroderma patients. The main objective of this collection of biological samples for scientific research will be the identification of new biomarkers associated with prognosis and treatment response to improve the management of SSc patients.

研究设计

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

入排标准

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

入选标准

  • Patient followed for SSc in the internal medicine or cardiology department of the Lille University Hospital
  • Fulfilling the ACR/EULAR and/or VEDOSS criteria for SSc
  • Being insured by the French social security system
  • Having the ability to understand the requirements of the study and provide informed consent

排除标准

  • Administrative reasons: unable to receive informed information, lack of social security coverage
  • Pregnant or lactating women
  • Persons deprived of liberty
  • Minors or protected adults
  • Persons who have refused or are unable to give informed consent
  • Persons in emergency situations

研究组 & 干预措施

Patients with systemic sclerosis

干预措施: Bio-banking without genetic analysis (Other)

结局指标

主要结局

Occurrence during the follow-up period of an aggravation defined as death, onset or worsening of organ damage

时间窗: Through study completion an average of 10 years

Identify biomarkers that are associated with disease prognosis and treatment response during 10 years of follow-up.

次要结局

  • EUSTAR score(Baseline and through study completion, an average of 10 years)
  • Medsger score(Baseline and through study completion, an average of 10 years)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

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