- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04482777
IL37,Tlymphocytes,NK Cells in Pathogenesis of ITP
August 7, 2023 updated by: Asmaa Mohamed Elsayed, Assiut University
IL37,Tlymphocytes ,NK Cells in Pathogenesis of Immune Thrombocytopenia.
To evaluate the role of IL37 in pathogenesis of ITP and to study the relation between IL37,Tlymphocytes,NK cells in ITP
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Idiopathic thrombocytopenia or immune thrombocytopenia (ITP) is a hematological condition which is characterized by a low platelet count of less than 100 x 109L .
Symptoms of ITP can vary but tend to be symptoms of thrombocytopenia in general, such as petechiae, purpura, mucosal bleeding and in the most severe cases fatal intracranial hemorrhage(1,2) Interleukin (IL)-37, a novel anti-inflammatory cytokine previously known as interleukin-1 family member 7 before it was renamed, has a pivotal role in the suppression of immune responses (3,4).
IL-37 is widely expressed in several types of cells, tissues and organs, including peripheral blood mononuclear cells (PBMCs) (5).
The major role of IL-37 is to decrease excessive inflammation in innate and adaptive immune diseases, mainly by inhibiting the expression, production and function of pro-inflammatory cytokines, including IL-1α, IL-6, tumor necrosis factor (TNF) and macrophage inflammatory protein-2.
The abundance of these cytokines has been reported to increase with the silencing of endogenous IL-37 in human blood cells (3,6).Aberrant expression of IL-37 has been observed in several inflammatory and autoimmune diseases However, the role of IL-37 in ITP has remained elusive.
Immune thrombocytopenia pathogenesis is a complicated process.
T cell immune abnormalities are involved in ITP pathogenesis.
These abnormalities include platelet auto-antigen reactive cytotoxic T cells, abnormal numbers and functions of T regulatory cells, loss of Th1/Th2 balance, megakaryocyte maturation abnormalities and abnormal T cell anergy.
Study Type
Observational
Enrollment (Estimated)
90
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Asmaa Mohamed
- Phone Number: 01027575354
- Email: mohamedasmaa550@yahoo.com
Study Contact Backup
- Name: Marwa Mohamed
- Phone Number: 01092288360
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 years to 60 years (Child, Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
To study initially enrolled 90 patients with ITP in Assiut hospital
Description
Inclusion Criteria:
- Patients with ITP (moderate and sever) different age group.
Exclusion Criteria:
- Patients with stroke and myocardial infarction,malignant tumors or pregnancy.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ITP
Patient newly diagnosied with ITP
|
Drug given to some patients with autoimmune disease
|
Treated
Patients with ITP recived treatment
|
Drug given to some patients with autoimmune disease
|
Control
Healthy people
|
Drug given to some patients with autoimmune disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To decrease the immunity complications in ITP patients
Time Frame: Baseline
|
Early detection of immunity complications in ITP patients
|
Baseline
|
To decrease case fatality rate
Time Frame: Baseline
|
Early detection of immunity complication will decrease mortality rate
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lambert MP, Gernsheimer TB. Clinical updates in adult immune thrombocytopenia. Blood. 2017 May 25;129(21):2829-2835. doi: 10.1182/blood-2017-03-754119. Epub 2017 Apr 17.
- Kistangari G, McCrae KR. Immune thrombocytopenia. Hematol Oncol Clin North Am. 2013 Jun;27(3):495-520. doi: 10.1016/j.hoc.2013.03.001.
- Chen Z, Qu W, Wang HQ, Xing LM, Wu YH, Liu ZY, Zhang Y, Liu H, Dong XF, Tao JL, Shao ZH. [Relationship of Peripheral Blood IL-37 Expression with T Lymphocytes Subsets and NK Cells in Patients with Primary Immune Thrombocytopenia]. Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Aug;27(4):1201-1207. doi: 10.19746/j.cnki.issn.1009-2137.2019.04.034. Chinese.
- Zhao Y, Ni X, Xu P, Liu Q, Sun T, Liu X, Ji X, Qiu J, Li J, Wang S, Han P, Peng J, Hou M, Li G. Interleukin-37 reduces inflammation and impairs phagocytosis of platelets in immune thrombocytopenia (ITP). Cytokine. 2020 Jan;125:154853. doi: 10.1016/j.cyto.2019.154853. Epub 2019 Sep 23. Erratum In: Cytokine. 2022 Jul;155:155900.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 30, 2023
Primary Completion (Estimated)
August 1, 2023
Study Completion (Estimated)
September 1, 2023
Study Registration Dates
First Submitted
July 19, 2020
First Submitted That Met QC Criteria
July 19, 2020
First Posted (Actual)
July 23, 2020
Study Record Updates
Last Update Posted (Actual)
August 9, 2023
Last Update Submitted That Met QC Criteria
August 7, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- Cellular immunity in ITP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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