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临床试验/NCT03508375
NCT03508375Unknown不适用

Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2018年5月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
75
试验地点
2
主要终点
fractalkine levels

研究概览

简要总结

Systemic Scleroderma (SCS) is an autoimmune disease characterized by vascular involvement, a dysimmune condition, cutaneous and visceral fibrosis. Interstitial lung disease (ILD) affects 75% of SSc patients and is the leading cause of death in SSc. No diagnostic or prognostic biomarkers of SSc-associated ILD have been validated to date. The search for such a serum biomarker is essential to assess the severity of these patients and to help the therapeutic management.

We have shown that soluble fractalkine is elevated in SSc patients, especially in SSc patients with ILD. The fractalkine is both an endothelial adhesion molecule and a chemokine that binds to the CX3CR1 receptor expressed by immune populations. It would thus reflect the vasculopathy and inflammation that lead to the fibrosing pulmonary involvement of this disease.

Objectives and means: We aim to perform a low-risk interventional biomedical research which main objective is the quantitative evaluation of soluble fractalkine in SSc patients with ILD in comparison with SSc patients without ILD. This epidemiological, explanatory, analytical, single-center study will comprise three groups: 1 / SSc without ILD (control group in the context of SSc), 2/ SSc with ILD and 3/ patients with idiopathic pulmonary fibrosis (IPF) (control group of the ILD). Secondary objectives are evaluation of: 1 / fractalkine levels in the IPF, 2 / correlations between fractalkine levels and severity of ILD and of SSc disease over time, 3 / correlations between fractalkine and 2 other biomarkers: KL-6 (marker of pulmonary fibrosis) and soluble CD146 (sCD146, marker of vasculopathy), 4 / predictive values of the decline in lung function of these 3 markers.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

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

  • Patients over the age of 18 with SSc with or without ILD with a medical follow up in AP-HM
  • Patients, followed at AP-HM, with IPF

排除标准

  • Impossibility of taking blood
  • Known diagnosis of respiratory disorders other than SSc-associated ILD and IPF
  • An infection in progress
  • An evolutive cancer
  • Chemotherapy or radiation therapy in progress
  • Pregnant or lactating women
  • Majors under guardianship
  • People staying in a health or social facility
  • People in emergency
  • Non-beneficiaries of a social security scheme
  • Persons deprived of their liberty

结局指标

主要结局

fractalkine levels

时间窗: 24 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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