Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)

NCT02821572 | Recruiting

• 1 other identifier: BONNOTTE PARI 2013
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (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

  through study completion, an average of 2 years

Secondary Outcomes (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

  through study completion, an average of 2 years

Study Arms (2)

patient

Biological: blood sample; Procedure: spleen sample

control

Biological: blood sample; Procedure: spleen sample

Interventions

blood sample BIOLOGICAL

control; patient

spleen sample PROCEDURE

control; patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with ITP Persons without autoimmune disease

You may qualify if:

• ITP group
• Patients who have provided written consent
• Patients over 18 years
• Patients with national health insurance
• Control Group
• Persons who have provided a written consent
• Persons over 18 years
• Persons with national health insurance
• Persons without autoimmune disease

You may not qualify if:

• Patients under guardianship
• Pregnancy

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU Dijon Bourgogne

Dijon, 21079, France

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Bernard BONNOTTE

CONTACT

3.80.29.34.32; bernard.bonnotte@chu-dijon.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: July 1, 2016
• Study Start: October 2, 2014
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

FR (1)