Defining an Immunological Signature Related to Lesion Location in Multiple Sclerosis

NCT ID: NCT05326048

Last Updated: 2023-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-03-09
• Study Completion Date: 2022-09-09

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

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Interventions

cytof analysis

cytof analysis of biological samples of CIS patients. Genomic analysis

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University hospital of Rennes

Rennes, , France

Countries

France

Other Identifiers

35RC21_3030_APOLLO

Identifier Type: -

Identifier Source: org_study_id