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Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP) (PTI Fc)

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: NCT02821572
Recruitment Status : Recruiting
First Posted : July 1, 2016
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Study Description
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Brief Summary:

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a peripheral destruction of platelets responsible for bleedings.

Monocytes/macrophages play a double role by phagocyting platelets recognized by autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell functions.

Fcgamma receptors (FcγR), that are represented by activating receptors (FcγRI, FcγRIIa, FcγRIII) and an inhibiting one (FcγRIIb), are involved in the regulation of macrophages and have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematous.

The aim of this study is to compare the expression of FcγR in patients with ITP on circulating monocytes and on splenic macrophages.


Condition or disease Intervention/treatment
Immune Thrombocytopenia Biological: blood sample Procedure: spleen sample

Study Design
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Study Type : Observational
Estimated Enrollment : 70 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
Actual Study Start Date : October 2, 2014
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : September 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
patient Biological: blood sample
Procedure: spleen sample
control Biological: blood sample
Procedure: spleen sample


Outcome Measures
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Primary Outcome Measures :
  1. 1. The expressions of the activating FcγRs and the inhibiting receptor (FcγRIIb) on monocytes will be compared between ITP patients at diagnosis and controls - physiological parameter [ Time Frame: through study completion, an average of 2 years ]

Secondary Outcome Measures :
  1. 1. The expressions of the activating FcγRs and the inhibiting receptor (FcγRIIb) on splenic macrophages will be compared between ITP patients and controls. - physiological parameter [ Time Frame: through study completion, an average of 2 years ]

Eligibility Criteria
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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:   Probability Sample
Study Population
Patients with ITP Persons without autoimmune disease
Criteria

Inclusion Criteria:

ITP group

  • Patients who have provided written consent
  • Patients over 18 years
  • Patients with national health insurance
  • Patients with ITP, defined as thrombocytopenia < 100 G/L, after exclusion of infection- or drug-related thrombocytopenia and malignant hemopathy.

Control Group

  • Persons who have provided a written consent
  • Persons over 18 years
  • Persons with national health insurance
  • Persons without autoimmune disease

Exclusion Criteria:

  • Patients under guardianship
  • Pregnancy
Contacts and Locations
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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): NCT02821572


Contacts
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Contact: Bernard BONNOTTE 3.80.29.34.32 ext 33 bernard.bonnotte@chu-dijon.fr

Locations
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France
CHU Dijon Bourgogne Recruiting
Dijon, France, 21079
Contact: Bernard BONNOTTE    3.80.29.34.32 ext 33    bernard.bonnotte@chu-dijon.fr   
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon
More Information
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02821572    
Other Study ID Numbers: BONNOTTE PARI 2013
First Posted: July 1, 2016    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Additional relevant MeSH terms:
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Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Hematologic Diseases
Purpura, Thrombocytopenic
Purpura
Blood Coagulation Disorders
 Thrombotic Microangiopathies
Hemorrhagic Disorders
Autoimmune Diseases
Immune System Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations