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

March 2, 2022 updated by: Rennes University Hospital
The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Rennes, France
        • CHU Rennes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

After selection of the patients and volunteers of interest (number and type of clinical and biological data available, heterogeneity of the chosen group...), the medical and imaging data of the patients will be transmitted by OFSEP from the EDMUS database and for healthy volunteers, the data of interest will be retrieved from the ABCD-SEP database

Patients CIS+ :60 Healthy Volunters : 30

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy volunteers
Genetic analysis of regions of interest
MS CIS+
Genetic analysis of regions of interest

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of immune subpopulations
Time Frame: 1 year
Correlations between the frequency of immune subpopulations, genetic profile and disease activity
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of immune subpopulations correlated to EDSS score
Time Frame: 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.)
1 year
Frequency of immune subpopulations correlated to disease progression delay
Time Frame: 1 year
Correlations between the frequency of immune subpopulations, genetic profile, and delay before disease progression
1 year
Frequency of immune subpopulations correlated to disease progression events
Time Frame: 1 year
Correlations between the frequency of immune subpopulations, genetic profile, and number of disease progression events
1 year
Frequency of immune subpopulations correlated to spinal lesions
Time Frame: 1 year
Correlations between the frequency of immune subpopulations, genetic profile, and number of new spinal lesions
1 year
Profiles of CIS+ patients
Time Frame: 1 year
Comparison of genetic and immunological profiles of CIS+ patients with healthy volunteers
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Laure Michel, Md, Rennes University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2020

Primary Completion (Actual)

March 2, 2022

Study Completion (Actual)

March 2, 2022

Study Registration Dates

First Submitted

August 10, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

March 2, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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