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

NCT05835050 | Unknown

• 1 other identifier: Soh-Med-22-11-04
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Immune Thrombocytopenic Purpura

Outcome Measures

Primary Outcomes (1)

• 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)

  16 months

Interventions

serum interleukin 10 level DIAGNOSTIC_TEST

b. Serum levels of IL-10 were measured using a quantitative enzyme-linked immunosorbent assay (ELISA)

Eligibility Criteria

• Age: 10 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.
• patients on chemotherapy and radiation therapy for cancer management

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 27882473 BACKGROUND

• 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.

  PMID: 23564312 BACKGROUND

• 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.

  PMID: 29945954 BACKGROUND

• 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.

  PMID: 28428120 BACKGROUND

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

Afndia A Mahmoud, resident

CONTACT

01276484457; afandeyatmahmoud@med.sohag.edu.eg

Eman H salama, Assistant professor

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Clinical pathology department at sohag university hospital

Study Record Dates

• First Submitted: April 18, 2023
• First Posted: April 28, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 28, 2023

Record last verified: 2023-04

Locations

EG (1)