跳至主要内容
临床试验/NCT02298777
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

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

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

研究点 (3)

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