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临床试验/NCT05326048
NCT05326048已完成不适用

Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

Rennes University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年3月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Differences in Immune profile

研究概览

简要总结

The objective of APOLLO is therefore to identify biomarkers associated with the CNS involvement phenotype in early MS patients.

详细描述

This is a multicenter, non-interventional, retrospective cohort study. In MS patients, a recent study suggests that the location of lesions in the brain relative to the ME is associated with different effector T cell responses (Th17 vs. Th1) to myelin proteins. Thus, lesion localization may be associated with different immune profiles.

Recently, high-resolution techniques such as mass cytometry (CyTOF) have allowed to better decipher immune diversity and thus to identify new potential therapeutic targets. The combination of CyTOF and high dimensional analysis techniques (viSNE, SPADE, MEM) offers robust and reliable methods to identify new subgroups within heterogeneous cell populations. Several studies have explored immune subpopulations by these methods, including B, T, NK or myeloid populations, from peripheral blood or tissues in other pathologies.

Genetic analysis of regions of interest in MS patients could thus allow the establishment of stratification elements potentiating the contribution of immunological markers.

The main objective is to evaluate the relevance of an immunological stratification by CyTOF, allowing the identification of new immune subpopulations associated with the lesion phenotype (brain or brain + ME), in a cohort of MS patients at the beginning of the disease (CIS+) The second objective will focus on genomic profiling of our two groups of MS patients (brain/brain + ME) for different genetic burdens of MS

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
  • •At least 18 years old
  • •Diagnosed with MS according to the 2017 criteria at the time of their last visit
  • •Not opposed to participating in the study
  • •Had at least one visit in the year following sampling
  • •Followed up for at least 1 year after collection.
  • •Signed OFSEP consent form

排除标准

  • •CIS patients with progressive MS

结局指标

主要结局

Differences in Immune profile

时间窗: 1 day

Comparison of immune profile by CyTOF between two groups of MS patients: "brain" versus "brain + ME" CITRUS algorithm will be used to perform a unsupervised hierarchical clustering of cells processed by cytof and SAM test to assess statistical differences in abundances or marker expression levels between groups of patients

次要结局

未报告次要终点

研究者

发起方
Rennes University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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