Regulatory B Cells and Chronic Immune Thrombocytopenia | NCT02891109

Studies
Regulatory B Cells and Chronic Immune Thrombocytopenia

NCT02891109

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Sep 7, 2016Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Purpura, Thrombocytopenic, Idiopathic
Regulatory B Cells

Interventions

Biological tests

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

Aug 2016

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

Jan 2015

Primary Completion Date

Sep 2015Actual

Completion Date

Sep 2015Actual

First Submitted Date

Sep 1, 2016

First Submission Date that Met QC Criteria

Sep 1, 2016

First Posted Date

Sep 7, 2016Estimated

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

Sep 1, 2016

Last Update Posted Date

Sep 7, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients group		Adults patients with chronic immune thrombocytopenia	Biological: Biological tests
control group		Adults without immune thrombocytopenia	Biological: Biological tests

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological tests	Biological	From the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry	control group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

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

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christophe Jamin, PhD	CHRU de Brest	Principal Investigator
Lenaig Le Clech, MD	CHRU BREST	Principal Investigator
Brigitte Pan-Petesh, MD	CHRU BREST	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016553	Purpura, Thrombocytopenic, Idiopathic

Ancestor Terms

ID	Term
D011696	Purpura, Thrombocytopenic
D011693	Purpura
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided