Study of Immune Thrombocytopenia Pathogenesis: (PTI PARI)

March 13, 2018 updated by: Centre Hospitalier Universitaire Dijon

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

89

Contacts and Locations

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

Study Locations

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

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

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

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
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
Time Frame: baseline
baseline
blood level T cell in ITP patients after treatments
Time Frame: change from baseline at 4 to 8 weeks
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
Time Frame: baseline
baseline
frequency of innate immune cells (dendritic cells, monocytes, NK cells…) and their functions in blood and spleens, in patients and in controls
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 years
level of T follicular helper cell
Time Frame: through study completion, an average of 3 years
through study completion, an average of 3 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)

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

Other Study ID Numbers

  • LORCERIE PARI 2010

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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