NCT02298777终止不适用
Metabolomic Analysis of Systemic Sclerosis
University Hospital, Strasbourg, France3 个研究点 分布在 1 个国家目标入组 121 人开始时间: 2014年12月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 121
- 试验地点
- 3
- 主要终点
- change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion.
研究概览
简要总结
Currently investigators do not have diagnostic and prognostic markers for SSc which almost always starts with a vascular disease (Raynaud's disease) isolated for several years.
The primary purpose is to highlight discriminating metabolic profiles depending on the characteristics of the disease, allowing early diagnosis of SSc at the onset of vascular lesions, by comparing the profiles of SSc beginners (<3 years) to established forms (> 3 years).
Secondary purposes:
- Prognosis: to study the metabolomics profile of SSc when a visceral complication occurs
- Diagnosis: to compare the metabolomics profile of SSc to undifferentiated connective tissue disease (UCDT), Raynaud's disease (RD), vascular disease (VD) and healthy controls
- Exploratory: to compare the metabolomics profile of blood, urine and skin of SSc patients
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
change of metabolomics profiles between SSc beginners (<3 years) and SSc established forms (> 3 years) at baseline inclusion.
时间窗: 1 point at patient's inclusion visit
Metabolomic profiles will be classified in a database and compared.
次要结局
- Study and comparison of discriminating metabolomics profiles for prognosis, diagnosis and exploration of SSc.(1st point at patient's inclusion visit (all arms) + 2nd point at patient's complication (group1) during 3 years)
研究者
研究点 (3)
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