Study of T Cells and Natural Killer Cells Expression in Patients With Immune Thrombocytopenic Purpura

October 13, 2021 updated by: Sara Mostafa Hashem, Sohag University
Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L. ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs). Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP.NK cells can also modulate cellular immunity in ITP patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L.ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months). ITP usually has a chronic course in adults whereas approximately 80-90% of children undergo spontaneous remission within weeks to months of disease onset. The main pathogenesis of ITP is the loss of immune tolerance to platelet auto-antigens, which results in increased platelet destruction and impaired thrombopoiesis by autoantibodies and cytotoxic T lymphocytes (CTLs).Platelet autoantibodies, particularly antiglycoprotein (GP) GPIIbIIIa and anti-GPIbIX, are known to cause thrombocytopenia in patients with ITP. Auto-Abs production often occurs due to the loss of self-tolerance and increased stimulation of the immune system. The immune system includes a variety of B- and T cells which cooperate with each other in T-cell-dependent antibody production reactions and play significant roles in humoral and cellular immunity. Although the pathogenesis of ITP has not been clearly understood, the autoreactive B- and T cells have been directly and indirectly involved in Auto-Abs production, respectively. As a main component of cellular immunity, T cells play an important role in body defense and peripheral tolerance. Changing number and function of these cells is closely associated with various diseases, including ITP. It can be stated that CD4+ T cells are indirectly involved in ITP pathogenesis by inducing the increased activity of B cells during Auto-Abs production. Cytotoxic T lymphocytes (CTLs) are another subgroup of T lymphocytes characterized by the expression of CD8+ surface marker, destroying the pathogenic factors via granzyme and perforin production. These cells are increased in ITP patients and are involved in platelet destruction via augmented production of granzyme and perforin. NK cells can also modulate cellular immunity in ITP patients.

Study Type

Observational

Enrollment (Anticipated)

40

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

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

1 year to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Group I: age and sex matched healthy control individuals. Group II: available number of ITP patients.

Description

Inclusion Criteria:

  • Patients with platelet less than 100 × 109/L diagnosed as immune thrombocytopenia according to bone marrow findings .

Exclusion Criteria:

  • Other causes of thrombocytopenia as:

    • Hypersplenism.
    • Bone marrow diseases including : aplastic anemia, leukemia and myelodysplastic syndromes.
    • Cancer treatments like chemotherapy and radiation therapy.
    • Exposure to toxic chemicals as arsenic and benzene.
    • Medications to treat bacterial infections (antibiotics)and treat seizures or blood thinner heparin.

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: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group I
age and sex matched healthy control individuals.
Diagnostic test: Laboratory investigations for control
  1. Complete blood picture .
  2. Erythrocyte sedimentation rate(ESR).
  3. Liver function tests .
  4. Kidney function tests.
  5. CD3, CD4,CD8,CD16,CD56 from peripheral blood samples by Flowcytometry
Group II
available number of ITP patients.
Diagnostic test: Laboratory investigations for patients
  1. Complete blood picture .
  2. Erythrocyte sedimentation rate(ESR).
  3. Liver function tests .
  4. Kidney function tests.
  5. Anti-nuclear antibodies test by immunoflourescence for ITP patients.
  6. Bone marrow aspiration (for diagnosis of ITP).
  7. CD3, CD4,CD8,CD16,CD56 from peripheral blood samples by Flowcytometry.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment the percentages of CD4+ cells from peripheral blood samples by Flowcytometry
Time Frame: within 3 days after collection of samples.

Methods of the study: All patients were subjected to:

  1. Full history taking.

  2. Laboratory investigations:

    1. Complete blood picture .
    2. Erythrocyte sedimentation rate(ESR).
    3. Liver function tests .
    4. Kidney function tests.
    5. Anti-nuclear antibodies test by immunofluorescence for ITP patients.
    6. Bone marrow aspiration (for diagnosis of ITP).
    7. CD3, CD4 from peripheral blood samples by Flowcytometry.
within 3 days after collection of samples.
Assessment the percentages of CD8+cells in ITP patients from peripheral blood samples by Flowcytometry .
Time Frame: within 3 days after collection of samples.

Methods of the study: All patients were subjected to:

  1. Full history taking.

  2. Laboratory investigations:

    1. Complete blood picture .
    2. Erythrocyte sedimentation rate(ESR).
    3. Liver function tests .
    4. Kidney function tests.
    5. Anti-nuclear antibodies test by immunofluorescence for ITP patients.
    6. Bone marrow aspiration (for diagnosis of ITP).
    7. CD3, CD8 from peripheral blood samples by Flowcytometry.
within 3 days after collection of samples.
Assessment the percentages of NK(CD16 +, CD56 +) cells in ITP patients from peripheral blood samples by Flowcytometry .
Time Frame: within 3 days after collection of samples.

Methods of the study: All patients were subjected to:

  1. Full history taking.

  2. Laboratory investigations:

    1. Complete blood picture .
    2. Erythrocyte sedimentation rate(ESR).
    3. Liver function tests .
    4. Kidney function tests.
    5. Anti-nuclear antibodies test by immunofluorescence for ITP patients.
    6. Bone marrow aspiration (for diagnosis of ITP).
    7. CD16, CD56 from peripheral blood samples by Flowcytometry.
within 3 days after collection of samples.

Collaborators and Investigators

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

Sponsor

Sohag University

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)

November 1, 2021

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

October 12, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 26, 2021

Study Record Updates

Last Update Posted (Actual)

October 26, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med-21-10-12

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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