Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : March 9, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire Dijon

Tracking Information
First Submitted Date June 23, 2016
First Posted Date July 1, 2016
Last Update Posted Date March 9, 2018
Actual Study Start Date October 2, 2014
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 8, 2018)
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 ]
Original Primary Outcome Measures
 (submitted: June 30, 2016)
• Compare the FcγRIIa/FcγRIIb ratio (activating/inhibiting) in ITP, in the blood and spleen of subjects with ITP and controls. [ Time Frame: through study completion, an average of 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: March 8, 2018)
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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
Official Title Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
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 Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with ITP Persons without autoimmune disease
Condition Immune Thrombocytopenia
Intervention
  • Biological: blood sample
  • Procedure: spleen sample
Study Groups/Cohorts
  • patient
    Interventions:
    • Biological: blood sample
    • Procedure: spleen sample
  • control
    Interventions:
    • Biological: blood sample
    • Procedure: spleen sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 30, 2016)
70
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 2020
Estimated Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Bernard BONNOTTE 3.80.29.34.32 ext 33 bernard.bonnotte@chu-dijon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02821572
Other Study ID Numbers BONNOTTE PARI 2013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Centre Hospitalier Universitaire Dijon
Study Sponsor Centre Hospitalier Universitaire Dijon
Collaborators Not Provided
Investigators Not Provided
PRS Account Centre Hospitalier Universitaire Dijon
Verification Date March 2018