Study of Immune Thrombocytopenia Pathogenesis: (PTI PARI)

Study of Immune Thrombocytopenia Pathogenesis: a Multicenter, Open and Controlled Study.

Immune thrombocytopenia (ITP) is an autoimmune disease characterized by a low platelet count responsible for bleedings. The disease is mostly mediated by antiplatelet antibodies produced by specific B cells. However, T cells are also involved but their role is not completely understood.

The aim of this study is to determine the implication of T cells in the pathogenesis of ITP, notably regulatory T cells (Treg, CD4+CD25highFoxp3+), cytotoxic T cells (CD3+CD8+) and T follicular helper cells (TFH, CD3+CD4+CXCR5+PD-1+ICOS+), in blood and in the spleen of primary ITP patients, compared to healthy controls.

Study Overview

• Status: Completed
• Conditions: Primary Immune Thrombocytopenia (ITP)
• Intervention / Treatment: Other: Blood samples; Other: Spleen samples

• Study Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25000
    • CHU de BESANCON
  • Dijon, France, 21079
    • CHU de Dijon
  • Metz, France, 57000
    • CHU de METZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with ITP

Description

Inclusion Criteria:

• Patients with ITP, defined as thrombocytopenia < 30 G/L, once causes related to infection, medication, systemic auto-immune disease or malignant hemopathy have been ruled out
• persons who have provided written informed consent

Exclusion Criteria:

• persons without national health insurance
• persons under 18 years old
• patients under guardianship
• pregnancy
• subjects suffering from a systemic auto-immune disease, cancer, a progressive infection, or treated with steroids or immunosuppressants.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Controls	Other: Blood samples
Patients with ITP	Other: Blood samples; Other: Spleen samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
blood level T cell in ITP patients and in healthy controls	baseline
blood level T cell in ITP patients after treatments	change from baseline at 4 to 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
blood level splenic T cell in ITP patients and in healthy controls	baseline
frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls	through study completion, an average of 3 years
level of T follicular helper cell	through study completion, an average of 3 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Dijon

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2011
• Primary Completion (Actual): March 12, 2015
• Study Completion (Actual): March 12, 2015

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 20, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 13, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: LORCERIE PARI 2010