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

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ClinicalTrials.gov Identifier: NCT04510350
Recruitment Status : Recruiting
First Posted : August 12, 2020
Last Update Posted : October 8, 2020
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

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

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Biomarkers analysis

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
Actual Study Start Date : February 19, 2020
Estimated Primary Completion Date : March 16, 2022
Estimated Study Completion Date : April 16, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
MS CIS+ Other: Biomarkers analysis
Genetic analysis of regions of interest

Healthy volunteers Other: Biomarkers analysis
Genetic analysis of regions of interest




Primary Outcome Measures :
  1. Frequency of immune subpopulations [ Time Frame: 1 year ]
    Correlations between the frequency of immune subpopulations, genetic profile and disease activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510350


Contacts
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Contact: Laure Michel, Md 2.99.28.43.21 ext 33 laure.michel@chu-rennes.fr
Contact: Marie-Laure Gervais, PhD 2.99.28.25.55 ext 33 marie-laure.gervais@chu-rennes.fr

Locations
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France
CHU Rennes Recruiting
Rennes, France
Contact: Laure Michel, Md         
Sponsors and Collaborators
Rennes University Hospital
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT04510350    
Other Study ID Numbers: 35RC19_8880_CISCO
First Posted: August 12, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases