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

Multiple Sclerosis Clinical Trial

— CISCO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04510350
• Other study ID #: 35RC19_8880_CISCO
• Status: Completed
• Start date: February 19, 2020
• Est. completion date: March 2, 2022

Study information

• Verified date: March 2022
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2, 2022
• Est. primary completion date: March 2, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients :

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Biomarkers analysis
Genetic analysis of regions of interest

Locations

Country	Name	City	State
France	CHU 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	Frequency of immune subpopulations	Correlations between the frequency of immune subpopulations, genetic profile and disease activity	1 year
Secondary	Frequency of immune subpopulations correlated to EDSS score	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.)	1 year
Secondary	Frequency of immune subpopulations correlated to disease progression delay	Correlations between the frequency of immune subpopulations, genetic profile, and delay before disease progression	1 year
Secondary	Frequency of immune subpopulations correlated to disease progression events	Correlations between the frequency of immune subpopulations, genetic profile, and number of disease progression events	1 year
Secondary	Frequency of immune subpopulations correlated to spinal lesions	Correlations between the frequency of immune subpopulations, genetic profile, and number of new spinal lesions	1 year
Secondary	Profiles of CIS+ patients	Comparison of genetic and immunological profiles of CIS+ patients with healthy volunteers	1 year