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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05326048
Other study ID # 35RC21_3030_APOLLO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 9, 2022
Est. completion date September 9, 2022

Study information

Verified date March 2023
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 9, 2022
Est. primary completion date September 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
cytof analysis
cytof analysis of biological samples of CIS patients. Genomic analysis

Locations

Country Name City State
France University hospital of Rennes Rennes

Sponsors (1)

Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Differences in Immune profile 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 1 day
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