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

NCT ID: NCT05093257

Last Updated: 2021-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Immune Thrombocytopenic Purpura

Keywords

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T cells and NK cells in ITP patients

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Group I

age and sex matched healthy control individuals.

Laboratory investigations for control

Intervention Type DIAGNOSTIC_TEST

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.

Laboratory investigations for patients

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Sara Mostafa Hashem

Resident of Clinical and Chemical Pathology

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sara M Hashem

Role: CONTACT

Phone: 01024758746

Email: [email protected]

Other Identifiers

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Soh-Med-21-10-12

Identifier Type: -

Identifier Source: org_study_id