Cellular microRNA Signatures in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- microRNA expression profiles in immune cell populations from RRMS patients
研究概览
简要总结
A limited number of studies on microRNA expression variation in immune cells have been reported in relapsing-remitting multiple sclerosis (RRMS). These studies have been performed mostly on a small scale and on whole blood mononuclear cells (PBMC).
In a number of cases, RRMS progresses to a severe secondary neurodegenerative form. In this context, it is important to look for biomarkers that could indicate the pathogenic activity of certain immune cell subpopulations.
详细描述
SEP-MIR is a prospective, single-center, descriptive study.
Participants will be recruited among adult patients with RRMS coming for a follow-up consultation in the Neurology Department, Nervous System Diseases Pole, at the hôpital Pitié - Salpêtrière (Paris).
As this is a descriptive study, the recruitment of 20 participants (10 patients with relapsing-remitting MS and 10 patients with relapsing-remitting MS) should meet the objectives of this study.
A 50 ml blood sample will be obtained from each participant and several clinical data regarding their pathology will be collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Caucasian population
- •Female and male individuals with an f/m ratio of 2-4/1
- •Individuals with RRMS according to the 2010 McDonald criteria for less than 15 years, with EDSS 1-6, in remission or relapse
- •Participant's condition compatible with a maximum of 50 ml of blood collection
- •Persons affiliated with a social security plan.
排除标准
- •MS treatment with steroidal anti-inflammatory drugs, immunomodulators or immunosuppressants within 2 months prior to blood collection
- •Persons with acute and chronic infectious disease, autoimmune/inflammatory disease or cancer other than MS
- •Pregnant or lactating women
- •Be under guardianship,
- •Be deprived of liberty by judicial or administrative decision, or be under legal protection.
结局指标
主要结局
microRNA expression profiles in immune cell populations from RRMS patients
时间窗: 2 years
RNAseq and/or Nanostring sequencing of PBMCs from RRMS patients
次要结局
- microRNA expression profiles in unstimulated and stimulated CD4+ T cell populations ex vivo from RRMS patients(2 years)
- microRNA expression profiles in monocytes from RRMS patients(2 years)