Regulatory B Cells and Chronic Immune Thrombocytopenia (PTIREG)

September 1, 2016 updated by: University Hospital, Brest

The Role of Regulatory B Cells in the Chronic Immune Thrombocytopenia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Brest, France, 29609
        • CHRU de Brest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Regulatory B cells functionality
Time Frame: 1 week
inhibition of T cells proliferation with co-culture B and T cells
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cytometry immunophenotyping of B and T cells
Time Frame: 1 week
characterization of B and T cells by flow cytometry
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Christophe Jamin, PhD, CHRU de Brest
  • Principal Investigator: Lenaig Le Clech, MD, CHRU Brest
  • Principal Investigator: Brigitte Pan-Petesh, MD, CHRU Brest

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

September 1, 2016

First Submitted That Met QC Criteria

September 1, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTIREG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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