Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— APOLLO  

Official title:

Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05326048
• Other study ID #: 35RC21_3030_APOLLO
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

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