Investigation of Novel Immunological Biomarkers by Mass Cytometry in Patients With Early Multiple Sclerosis (CISCO)
CISCO
1 other identifier
observational
90
1 country
1
Brief Summary
The objective of CISCO is therefore to identify prognostic biomarkers of MS activity in early-stage patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 19, 2020
CompletedFirst Submitted
Initial submission to the registry
August 10, 2020
CompletedFirst Posted
Study publicly available on registry
August 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2022
CompletedMarch 3, 2022
March 1, 2022
2 years
August 10, 2020
March 2, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Frequency of immune subpopulations
Correlations between the frequency of immune subpopulations, genetic profile and disease activity
1 year
Secondary Outcomes (5)
Frequency of immune subpopulations correlated to EDSS score
1 year
Frequency of immune subpopulations correlated to disease progression delay
1 year
Frequency of immune subpopulations correlated to disease progression events
1 year
Frequency of immune subpopulations correlated to spinal lesions
1 year
Profiles of CIS+ patients
1 year
Study Arms (2)
MS CIS+
Healthy volunteers
Interventions
Eligibility Criteria
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
You may qualify if:
- 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
You may not qualify if:
- CIS patients with progressive MS
- Healthy volunteers :
- 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
- Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Rennes
Rennes, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laure Michel, Md
Rennes University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2020
First Posted
August 12, 2020
Study Start
February 19, 2020
Primary Completion
March 2, 2022
Study Completion
March 2, 2022
Last Updated
March 3, 2022
Record last verified: 2022-03