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Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05326048
Acronym
APOLLO
Enrollment
60
Registered
2022-04-13
Start date
2022-03-09
Completion date
2022-09-09
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

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

Detailed description

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

Interventions

cytof analysis of biological samples of CIS patients. Genomic analysis

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Differences in Immune profile1 dayComparison 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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026