Skin Fibrosis Analysis by Raman Spectroscopy in Systemic Sclerosis (RAMSES)
Systemic sclerosis (SSc) is a rare connective tissue disease characterized by a high clinical heterogeneity with unpredictable evolution that could engage functional and life-threatening prognosis. Most of patients develop skin fibrosis gradually spreading. Two clinical distinct forms are described according to the extension of skin fibrosis: limited (lSSc) and diffuse (dSSc) SSc. It is now admitted that a spreading of skin fibrosis is associated with poor prognosis. This disease can be complicated by pulmonary arterial hypertension (PAH), interstitial lung disease (ILD) and scleroderma renal crisis (SRC) representing the main causes of death in SSc. Usually, PAH is associated with lSSc, and ILD and SRC are associated with dSSc. Prognosis is also different regarding skin phenotype with a higher mortality rate in dSSc.
An easy score, called modified Rodnan skin score, is commonly used in clinical practice to evaluate the spreading and severity of skin fibrosis, but this score is hardly reproducible. Ultrasound can be used to measure skin thickness and is more reproducible than the Rodnan skin score. Nevertheless, non-invasive analysis of fibrosis composition in different areas is not possible with these two technics.
Thus, in this study we will investigate Raman spectroscopy, a non-invasive technic based on the interaction of a low-intensity laser with matter.
研究概览
详细说明
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:Amélie SERVETTAZ
- 电话号码:0033 03 26 83 27 69
- 邮箱:aservettaz@chu-reims.fr
学习地点
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Reims、法国
- Damien JOLLY
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接触:
- Amélie SERVETTAZ
- 电话号码:0033 03 26 83 27 69
- 邮箱:aservettaz@chu-reims.fr
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
inclusion criteria :
- patients with SSc, according to ACR criteria
- older than 18-years-old exclusion criteria :
- younger than 18-years-old
- patient protected by law
学习计划
研究是如何设计的?
设计细节
- 观测模型:病例对照
- 时间观点:预期
队列和干预
团体/队列 |
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Systemic sclerosis group
Patients with systemic sclerosis
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No Systemic sclerosis group
Patients without systemic sclerosis
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Raman spectroscopy
大体时间:at 6 months
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at 6 months
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Raman spectroscopy
大体时间:at 12 months
|
at 12 months
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Raman spectroscopy
大体时间:at 24 months
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at 24 months
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Raman spectroscopy
大体时间:at 36 months
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at 36 months
|
合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始 (预期的)
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.