Investigation of Novel Immunological Biomarkers by Mass C... | NCT04510350

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

NCT04510350

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Mar 3, 2022Actual

Enrollment

90Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Biomarkers analysis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 19, 2020Actual

Primary Completion Date

Mar 2, 2022Actual

Completion Date

Mar 2, 2022Actual

First Submitted Date

Aug 10, 2020

First Submission Date that Met QC Criteria

Aug 10, 2020

First Posted Date

Aug 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 2, 2022

Last Update Posted Date

Mar 3, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

90Actual

Label	Type	Description	Intervention Names
MS CIS+			Other: Biomarkers analysis
Healthy volunteers			Other: Biomarkers analysis

Name	Type	Description	Arm Group Labels	Other Names
Biomarkers analysis	Other	Genetic analysis of regions of interest	Healthy volunteers MS CIS+

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases