Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 39 for:    idiopathic intracranial hypertension

Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS) (4BLMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03796611
Recruitment Status : Not yet recruiting
First Posted : January 8, 2019
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

Tracking Information
First Submitted Date January 3, 2019
First Posted Date January 8, 2019
Last Update Posted Date January 8, 2019
Estimated Study Start Date February 2019
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 3, 2019)
to compare the percentage of 4 BL cells in blood between MS patients and healthy controls [ Time Frame: Baseline: one session ]
4 BL are defined using cytometric parameters
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 3, 2019)
  • to compare the percentage of 4 BL cells in blood between MS patients and patients with inflammatory and non inflammatory neurological disease [ Time Frame: Baseline: one session ]
    4 BL are defined using cytometric parameters
  • to compare the percentage of 4 BL cells in CSF between MS patients and patients with inflammatory and non inflammatory neurological disease [ Time Frame: Baseline: one session ]
    4 BL are defined using cytometric parameters
  • to analyse over time the evolution of 4BL percentages in blood in MS patients [ Time Frame: 5 blood collection at baseline, 3, 6, 12, and 24 months after baseline ]
    4 BL are defined using cytometric parameters
  • to constitute at Baseline a biological bank with mononuclear cells from all the groups fo that study [ Time Frame: Baseline: one session ]
    peripheral blood mononuclear cells from MS, non inflammatory neurological and other inflammatory neurological disease groups
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)
Official Title Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)
Brief Summary

Recent works highlight the B cells involvement in multiple sclerosis (MS) pathology but their role remains poorly understood. It was previously described that activated memory B cells called 4BL due to the increased expression of 4-1BBL, an activation marker, induce pro-inflammatory response by activating T CD8+ lymphocytes. Those 4BL cells are also described in systemic inflammation in 80 years old people explaining the poor efficiency of vaccination in that sub population. Those 4BL cells can also induce anti-tumoral T cell response.

The hypothesize is that 4BL may induce a pathogenic inflammatory response in MS.

Detailed Description

the aim to compare the proportion of peripheral (blood) 4 BL cells but also 4-BL cells in cerebro spinal fluid (CSF) in MS compared to healthy controls and to other inflammatory neurological disease but also non inflammatory neurological disease.

For all groups of patients and controls we will collect blood and CSF only once (at diagnosis time for patients).

Blood collect from healthy controls will come from transfusion volunteers and we won't have CSF from them.

For patients from the MS group, the blood collect will be sequential at diagnosis, 3, 6, 12 and 24 months after during the follow up.

In the blood and CSF we will evaluate:

  • percentage of 4 BL cells. 4 BL cells are found using cytometric parameters
  • capacity of 4 BL cells to induce inflammatory response in vitro: percentage of induced activated TCD8 proliferation after cell culture using extracellular and intracellular cytometric parameters
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
blood sampling and Cerebrospinal fluid at baseline and five sequential blood sampling for MS groups
Sampling Method Probability Sample
Study Population MS patients and controls: healthy controls and patients having non-MS neurological inflammatory disease and patients having other non inflammatory neurological disease.
Condition Multiple Sclerosis
Intervention Not Provided
Study Groups/Cohorts
  • multiple sclerosis patient
    MS is defined according to McDonald criteria 2017. MS patients included have a disease duration of less than 1 year
  • other neurological inflammatory disease
    autoimmune encephalitis, myasthenia gravis, chronic inflammatory demyelinating polyradiculitis
  • neurological non inflammatory disease
    benign intracranial hypertension, degenerative disorder
  • healthy controls
    transfusion volunteers from transfusion center
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: January 3, 2019)
172
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2021
Estimated Primary Completion Date October 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria for MS group:

  • MS defined by McDonald 2017 criteria with a disease duration of less than 1 year
  • between 18 and 60 years old patients
  • naïve of any immune therapy or steroid intake
  • patients who signed consent to the study

Inclusion Criteria for controls with inflammatory of non inflammatory neurological disease:

  • patients who signed consent to the study
  • between 18 and 60 years old patients
  • naïve of any steroid intake or immune therapy

Inclusion criteria for healthy controls:

  • control who signed consent at transfusion center for their blood collect to be used for study
  • between 18 and 60 years old patients
  • naïve of any steroid intake or immune therapy

Exclusion Criteria:

  • pregnancy or breast-feeding
  • patients or controls unable to sign the consent or to consent
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Hélène ZEPHIR, MD, PhD 3 20 44 68 46 ext +33 helene.zephir@chru-lille.fr
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03796611
Other Study ID Numbers 2016_04
2017-A00835-48 ( Other Identifier: ID-RCB number, ANSM )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party University Hospital, Lille
Study Sponsor University Hospital, Lille
Collaborators Not Provided
Investigators
Principal Investigator: Hélène ZEPHIR, MD, PhD University Hospital, Lille
PRS Account University Hospital, Lille
Verification Date January 2019