Prognostic Value of CD Markers in Immune Thrombocytopenic Purpura

March 14, 2020 updated by: Esraa Ahmed Mahmoud, Assiut University
In this study, we will focus on the independent prognostic relevance of the expressions of CD38, CD4, CD56, CD11b and CD19 markers in immune cells with platelet changes in patients with newly diagnosed and chronic ITP.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Immune thrombocytopenia (ITP), previously called idiopathic thrombocytopenia purpura, is an autoimmune disorder characterized by a severe reduction in peripheral blood platelet count. In healthy individuals, normal platelet count ranges from 150-450 × 109/L, while in thrombocytopenia counts fall to less than 100 × 109/L ( Provan et al., 2010).

Based on duration, ITP is differentiated into three phases. Newly diagnosed ITP occurs within 3 months of diagnosis, persistent ITP is present 3-12 months after diagnosis, and chronic ITP lasts >12 months since diagnosis (Roberto, 2011).

Autoantibodies against platelet glycoproteins (GPs), including GPIIb/IIIa and GPIb/IX, have been considered to play a crucial role in ITP (Nomura, 2016) . In addition to platelet destruction, impaired maturation of megakaryocytes can be associated with reduced platelet production in ITP (Muna et al., 2015).

Furthermore, considerable attention has been recently paid to the dysregulation of a new B-cell subset known as regulatory B cells (Breg) in ITP (Li et al., 2012). This B-cell subset is characterized by CD19+CD38+ expression, promoting peripheral tolerance and reducing the function of autoreactive T-helper (Th) CD4+ cells via production of interleukin 10 (IL-10) (Flores-Borja et al., 2013). So they are an interesting cell population in diseases characterized by an unbalance in the immune system, such as autoimmune diseases, chronic infections, cancer and graft rejection.( Horikawa et al., 2013).

In ITP, as a result of the defective function of Breg and also Treg (regulatory T) cells, platelet autoreactive Th CD4+ cells undergo clonal expansion (McKenzie et al., 2013). so the presence of activated platelet-specific autoreactive T cells that respond to autologous platelet antigens participating in autoantibody production in ITP via interaction with autoreactive B cells (Solanilla et al., 2005).

Since the early 1980s, many studies have documented decreased natural killer (NK) cell numbers and impairment of NK cell function in the peripheral blood of patients with autoimmune diseases such as multiple sclerosis, systemic lupus erythematosus, Sjögren's syndrome, rheumatoid arthritis, and type I diabetes (hussein et al., 2017). Furthermore, in many studies, a correlation has been found between NK cell number and activity with disease progression or remission in multiple sclerosis (MS) and systemic lupus erythematosus (SLE). (Riccieri et al., 2000).

Nk cells are identified by the expression of CD16 and CD56 surface markers, account for 5-15% of PB cells in healthy individuals .NK cells have a crucial role in the initial defense against infections in innate immunity and are particularly important in responding to viral infections (French and Yokoyama., 2004).

This finding suggests that CD16+CD56+ NK cells may play a role in the pathogenesis and prognosis of autoimmune diseases.

CD11b+ monocytes can regulate adaptive immunity by adjustment of different T-cell subsets (Kusmartsev et al., 2000). Recently showed that monocytes derived from the whole blood of chronic ITP patients promoted the development of Th CD4+ subset (Zhong et al., 2012).

Although the majority of these abnormalities can appear as the increased or decreased expressions of some CD markers in the involved cells, there have been few studies on the prognostic value of CD markers' expressions in immune cells for ITP.

Study Type

Observational

Enrollment (Anticipated)

68

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 Contact Backup

  • Name: rania mohammed mahmoud, assistant prof.
  • Phone Number: +201000019198

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

2 years to 60 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Assiut university hospital - clinical hematology unit.

Description

Inclusion Criteria:

  • Patients with thrombocytopenia were identified by their medical records. According to guidelines for the investigation and management of ITP, its diagnosis in thrombocytopenic patients was based on the following criteria: the presence of thrombocytopenia (platelet counts <100 9 103/lL), patient's history, physical examination, normal concentration of hemoglobin and white blood cells (WBC), PB smear examination, normal or increased number of megakaryocytes with normal myeloid and erythroid progenitors in bone marrow (BM) smears. The absence of other diseases causing thrombocytopenia, including HIV and hepatitis C infection, SLE, aplastic anemia, megaloblastic anemia, and lymphoproliferative disorders was confirmed by BM aspiration assays. In chronic ITP : ITP patients lasting for more than 12 months

Exclusion Criteria:

  • The prescence of other diseases causing thrombocytopenia, including HIV and hepatitis C infection, SLE, aplastic anemia, megaloblastic anemia and lymphoproliferative disorders was confirmed by BM aspiration assays

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
group 1
control group with normal platelet count
Diagnostic test: CD4, CD19, CD38, CD56 and CD11b
measuring CD markers by flowcytometry
group 2
patients with acute ITP
Diagnostic test: CD4, CD19, CD38, CD56 and CD11b
measuring CD markers by flowcytometry
group 3
patients with chronic ITP
Diagnostic test: CD4, CD19, CD38, CD56 and CD11b
measuring CD markers by flowcytometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
measuring level of research CD markers in immue cells
Time Frame: one year

in acute ITP patients : at time of diagnosis and after treatment and return of platelets count to normal count.

in chronic ITP patients : measuring of research CD markers once.
one year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Essam ELdeen abdmohsen mohammed, Professor, +201001971906

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

May 1, 2020

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

August 1, 2021

Study Registration Dates

First Submitted

March 14, 2020

First Submitted That Met QC Criteria

March 14, 2020

First Posted (Actual)

March 17, 2020

Study Record Updates

Last Update Posted (Actual)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 14, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CD markers in ITP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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