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Assessment of Serum interleukin10 Level in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital

Primary Purpose

Immune Thrombocytopenic Purpura

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
serum interleukin 10 level
Sponsored by
Sohag University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Immune Thrombocytopenic Purpura

Eligibility Criteria

10 Months - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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. patients on chemotherapy and radiation therapy for cancer management

Sites / Locations

  • Sohag University Hospital

Outcomes

Primary Outcome Measures

assessment of serum interleukin 10 level in patients with ITP
b. Serum levels of IL-10 were measured using a quantitative enzyme-linked immunosorbent assay (ELISA)

Secondary Outcome Measures

Full Information

First Posted
April 18, 2023
Last Updated
April 18, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05835050
Brief Title
Assessment of Serum interleukin10 Level in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital
Official Title
Assessment of Serum interleukin10 Level in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
October 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Autoimmune diseases are characterized by various factors that contribute to a breakdown in self-tolerance, that is, the ability of the immune system to effectively distinguish self from non-self and to refrain from attacking self. Autoimmune diseases include a broad spectrum of disorders, such as idiopathic thrombocytopenic purpura, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, and inflammatory bowel disease. Although significant progress has been achieved in the development of approaches to the treatment of autoimmune diseases, the etiologies, and pathogenesis of autoimmune diseases remain obscure (Tao et al., 2016) Immune thrombocytopenia (ITP) is an autoimmune bleeding disorder characterized by bleeding due to isolated thrombocytopenia with platelet count less than 100 × 109/L (Neunert et al., 2019). ITP is classified based on course of disease into acute (3- <12 months), and chronic (≥12 months) (Provan et al., 2019). ITP usually has a chronic course in adults (Moulis et al., 2017) whereas approximately 8090% of children undergo spontaneous remission within weeks to months of disease onset (Heitink et al., 2018). 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) (Adiua et al., 2017). Among these abnormalities include the increased number of the T helper 1 (Th1) cells (Panitsas et al.,2004). the decreased number or defective suppressive function of regulatory T cells (Tregs) (Yu et al., 2008) , and the

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenic Purpura

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Diagnostic Test
Intervention Name(s)
serum interleukin 10 level
Intervention Description
b. Serum levels of IL-10 were measured using a quantitative enzyme-linked immunosorbent assay (ELISA)
Primary Outcome Measure Information:
Title
assessment of serum interleukin 10 level in patients with ITP
Description
b. Serum levels of IL-10 were measured using a quantitative enzyme-linked immunosorbent assay (ELISA)
Time Frame
16 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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. patients on chemotherapy and radiation therapy for cancer management
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afndia A Mahmoud, resident
Phone
01276484457
Email
afandeyatmahmoud@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Eman H salama, Assistant professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Magdy m amen, professor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27882473
Citation
Tao JH, Cheng M, Tang JP, Liu Q, Pan F, Li XP. Foxp3, Regulatory T Cell, and Autoimmune Diseases. Inflammation. 2017 Feb;40(1):328-339. doi: 10.1007/s10753-016-0470-8.
Results Reference
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PubMed Identifier
23564312
Citation
Zhan Y, Hua F, Ji L, Wang W, Zou S, Wang X, Li F, Cheng Y. Polymorphisms of the IL-23R gene are associated with primary immune thrombocytopenia but not with the clinical outcome of pulsed high-dose dexamethasone therapy. Ann Hematol. 2013 Aug;92(8):1057-62. doi: 10.1007/s00277-013-1731-3. Epub 2013 Apr 7.
Results Reference
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PubMed Identifier
29945954
Citation
Heitink-Polle KMJ, Uiterwaal CSPM, Porcelijn L, Tamminga RYJ, Smiers FJ, van Woerden NL, Wesseling J, Vidarsson G, Laarhoven AG, de Haas M, Bruin MCA; TIKI Investigators. Intravenous immunoglobulin vs observation in childhood immune thrombocytopenia: a randomized controlled trial. Blood. 2018 Aug 30;132(9):883-891. doi: 10.1182/blood-2018-02-830844. Epub 2018 Jun 26.
Results Reference
background
PubMed Identifier
28428120
Citation
Audia S, Mahevas M, Samson M, Godeau B, Bonnotte B. Pathogenesis of immune thrombocytopenia. Autoimmun Rev. 2017 Jun;16(6):620-632. doi: 10.1016/j.autrev.2017.04.012. Epub 2017 Apr 17.
Results Reference
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Assessment of Serum interleukin10 Level in Patients With Immune Thrombocytopenic Purpura at Sohag University Hospital

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