- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510350
Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO) (CISCO)
Study Overview
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
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Rennes, France
- CHU Rennes
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Healthy volunteers
|
Genetic analysis of regions of interest
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MS CIS+
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Genetic analysis of regions of interest
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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
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1 year
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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
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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
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Correlations between the frequency of immune subpopulations, genetic profile, and number of new spinal lesions
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1 year
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Profiles of CIS+ patients
Time Frame: 1 year
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Comparison of genetic and immunological profiles of CIS+ patients with healthy volunteers
|
1 year
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laure Michel, Md, Rennes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC19_8880_CISCO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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