Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)

Recruiting

• Conditions: Immune Thrombocytopenia
• Interventions: Biological: blood sample; Procedure: spleen sample

• Registration Number: NCT02821572
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-02
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-30
• Study First Posted: 2016-07-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patient	blood sample	-
control	spleen sample	-
patient	spleen sample	-
control	blood sample	-

Primary Outcome Measures

Name	Time	Method
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	through study completion, an average of 2 years

Secondary Outcome Measures

Name	Time	Method
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	through study completion, an average of 2 years

Trial Locations

Locations (1)

CHU Dijon Bourgogne; 🇫🇷 Dijon, France