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

NCT ID: NCT05835050

Last Updated: 2023-04-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-31
• Study Completion Date: 2024-10-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

serum interleukin 10 level

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

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 10 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Afndia Abdelnaeem Mahmoud

Resident at Clinical pathology department at sohag university hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University Hospital

Sohag, , Egypt

Countries

Egypt

Central Contacts

Afndia A Mahmoud, resident

Role: CONTACT

Phone: 01276484457

Email: afandeyatmahmoud@med.sohag.edu.eg

Eman H salama, Assistant professor

Role: CONTACT

Facility Contacts

Magdy m amen, professor

Role: primary

References

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.

Reference Type: BACKGROUND

PMID: 27882473 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23564312 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29945954 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 28428120 (View on PubMed)

Other Identifiers

Soh-Med-22-11-04

Identifier Type: -

Identifier Source: org_study_id