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OpenTrials
Completed

NCT Number: NCT05326048

Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University hospital of Rennes

Rennes, 35000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • CIS patients with progressive MS

Treatment and study plan

cytof analysis

Other

cytof analysis of biological samples of CIS patients. Genomic analysis

Primary outcomes

  1. Differences in Immune profile

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: APOLLO

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 13, 2022
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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