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Regulatory B Cells and Chronic Immune Thrombocytopenia (PTIREG)

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ClinicalTrials.gov Identifier: NCT02891109
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Brest

Brief Summary:
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown.

Condition or disease Intervention/treatment
Purpura, Thrombocytopenic, Idiopathic Regulatory B Cells Biological: Biological tests

Detailed Description:
The chronic immune thrombopenia is an autoimmune disease caused by B cells. These cells produce anti platelets and megakaryocytes antibodies. Some B cells, named regulatory B cells, are known to control other cells. Their action in chronic immune thrombopenia is actually unknown. In our cohort of chronic immune thrombopenia and controls, we realized a flow cytometry analyze of B and T cells and a co-culture to determine regulatory B cells functionality.

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Study Type : Observational
Actual Enrollment : 36 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Role of Regulatory B Cells in the Chronic Immune Thrombocytopenia
Study Start Date : January 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015


Group/Cohort Intervention/treatment
patients group
Adults patients with chronic immune thrombocytopenia
Biological: Biological tests
From the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry

control group
Adults without immune thrombocytopenia
Biological: Biological tests
From the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry




Primary Outcome Measures :
  1. Regulatory B cells functionality [ Time Frame: 1 week ]
    inhibition of T cells proliferation with co-culture B and T cells


Secondary Outcome Measures :
  1. Cytometry immunophenotyping of B and T cells [ Time Frame: 1 week ]
    characterization of B and T cells by flow cytometry



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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
patients with a Purpura, Thrombocytopenic, Idiopathic, in chronic phase (>12 months) and healthy volunteers as control residents in Brest town, France.
Criteria

Inclusion Criteria:

  • Purpura, Thrombocytopenic, Idiopathic, chronic phase (>12 months)
  • no treatment or thrombopoietin receptor agonists

Exclusion Criteria:

  • < 18 years
  • Purpura, Thrombocytopenic, Idiopathic, acute phase
  • pregnancy
  • others causes of thrombopenia

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): NCT02891109


Locations
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France
CHRU de Brest
Brest, France, 29609
Sponsors and Collaborators
University Hospital, Brest
Investigators
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Principal Investigator: Christophe Jamin, PhD CHRU de Brest
Principal Investigator: Lenaig Le Clech, MD CHRU Brest
Principal Investigator: Brigitte Pan-Petesh, MD CHRU Brest
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Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT02891109    
Other Study ID Numbers: PTIREG
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura
Purpura, Thrombocytopenic, Idiopathic
Purpura, Thrombocytopenic
Blood Platelet Disorders
Hematologic Diseases
Blood Coagulation Disorders
Hemorrhage
Pathologic Processes
Skin Manifestations
Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases