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

February 19, 2024 updated by: Centre Hospitalier Universitaire Dijon

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

70

Contacts and Locations

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

Study Contact

Study Locations

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

Yes

Sampling Method

Probability Sample

Study Population

Patients with ITP Persons without autoimmune disease

Description

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 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
control
Biological: blood sample
Procedure: spleen sample
patient
Biological: blood sample
Procedure: spleen sample

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire Dijon

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 (Actual)

October 2, 2014

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 23, 2016

First Submitted That Met QC Criteria

June 30, 2016

First Posted (Estimated)

July 1, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BONNOTTE PARI 2013

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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