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

NCT05093257 | Unknown

• 1 other identifier: Soh-Med-21-10-12
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Immune Thrombocytopenic Purpura

Keywords

T cells and NK cells in ITP patients

Outcome Measures

Primary Outcomes (3)

• Assessment the percentages of CD4+ cells from peripheral blood samples by Flowcytometry

  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 .

  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 .

  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.

Study Arms (2)

Group I

age and sex matched healthy control individuals.

Diagnostic Test: Laboratory investigations for control

Group II

available number of ITP patients.

Diagnostic Test: Laboratory investigations for patients

Interventions

Laboratory investigations for control 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 I

Laboratory investigations for patients 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.

Group II

Eligibility Criteria

• Age: 1 Year - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag University: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Central Study Contacts

Sara M Hashem

CONTACT

01024758746; sara011095@med.sohag.edu.eg

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Clinical and Chemical Pathology

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 26, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 26, 2021

Record last verified: 2021-10