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Trial record 34 of 37 for:    idiopathic intracranial hypertension

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

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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

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.


Condition or disease
Multiple Sclerosis

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

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Study Type : Observational
Estimated Enrollment : 172 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine


Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Biospecimen Retention:   Samples Without DNA
blood sampling and Cerebrospinal fluid at baseline and five sequential blood sampling for MS groups


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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

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): NCT03796611


Contacts
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Contact: Hélène ZEPHIR, MD, PhD 3 20 44 68 46 ext +33 helene.zephir@chru-lille.fr

Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Hélène ZEPHIR, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03796611     History of Changes
Other Study ID Numbers: 2016_04
2017-A00835-48 ( Other Identifier: ID-RCB number, ANSM )
First Posted: January 8, 2019    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
immunology
B cells

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases