Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)

Completed

• Conditions: Multiple Sclerosis
• Interventions: Other: Biomarkers analysis

• Registration Number: NCT04510350
• Lead Sponsor: Rennes University Hospital

Brief Summary

The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-19
• Study First Submitted: 2020-08-10
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Status Verified: 2022-03
• Primary Completion: 2022-03-02
• Study Completion: 2022-03-02
• Last Update Submitted: 2022-03-02
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients with clinically isolated syndrome (CIS) participating in the OFSEP cohort (French MS Observatory)
• At least 18 years of age
• Diagnosed with MS according to criteria 2017 at the time of their last visit.
• Non-opposition to participation in the study
• Having had at least one visit in the year following collection
• Follow-up for at least 1 year after collection.
• Having signed the OFSEP consent

Exclusion Criteria

• CIS patients with progressive MS

Healthy volunteers :

Inclusion Criteria:

• Age 18 years or older
• Having participated in the ABCD-SEP clinical trial promoted by the Rennes University Hospital (NCT03744351).
• Matched on age and sex to patients of interest in the OFSEP cohort
• Not having objected to participation in the study

Exclusion Criteria:

• Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Biomarkers analysis	-
MS CIS+	Biomarkers analysis	-

Primary Outcome Measures

Name	Time	Method
Frequency of immune subpopulations	1 year	Correlations between the frequency of immune subpopulations, genetic profile and disease activity

Secondary Outcome Measures

Name	Time	Method
Frequency of immune subpopulations correlated to EDSS score	1 year	Correlations between the frequency of immune subpopulations, genetic profile, and EDSS score ((Expanded Disability Status Scale, method of quantifying disability in multiple sclerosis, steps 1.0 to 4.5 refer to people with MS who are fully ambulatory. EDSS steps 5.0 to 9.5 are defined by the impairment to ambulation.)
Frequency of immune subpopulations correlated to disease progression delay	1 year	Correlations between the frequency of immune subpopulations, genetic profile, and delay before disease progression
Profiles of CIS+ patients	1 year	Comparison of genetic and immunological profiles of CIS+ patients with healthy volunteers
Frequency of immune subpopulations correlated to disease progression events	1 year	Correlations between the frequency of immune subpopulations, genetic profile, and number of disease progression events
Frequency of immune subpopulations correlated to spinal lesions	1 year	Correlations between the frequency of immune subpopulations, genetic profile, and number of new spinal lesions

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France