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Expression of CD19 Complex in Lymphoproliferative Disorders (CD19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04734470
Recruitment Status : Not yet recruiting
First Posted : February 2, 2021
Last Update Posted : February 4, 2021
Sponsor:
Information provided by (Responsible Party):
Mahran mohamed hussein mahran, Assiut University

Brief Summary:
  1. To study the expression pattern of CD19(cluster of differentiation antigen19) complex in lymphoproliferative disorders and its diagnostic value.
  2. To investigate the biological significance of CD19 complex expression in lymphoproliferative disorders.
  3. To explore the possibility of ectopic expression of CD19 complex in non B-lineage lymphoproliferative disorders.

Condition or disease Intervention/treatment
Lymphoproliferative Disorders Diagnostic Test: Flow cytometry

Detailed Description:

Lymphoproliferative disorders (LPD)comprise a heterogeneous group of diseases characterized by uncontrolled production of lymphocytes that cause monoclonal lymphocytosis, lymphadenopathy and bone marrow infiltration.They Typically occur in people who have a compromised immune system with highly variable clinical course.

Lymphoproliferative disorders are immunomorphologically and clinically heterogeneous. The two major types of lymphocytes are B cells and T cells, which are derived from pluripotent hematopoietic stem cells in the bone marrow.

Lymphoproliferative disorders include; Follicular lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, hairy cell leukemia, Hemophagocytic lymphohistiocytosis (HLH), B-cell lymphomas, T-cell lymphomas, multiple myeloma, Waldenström's macroglobulinemia, Wiskott Aldrich syndrome, Langerhans cell histiocytosis (LCH), Lymphocyte-variant hypereosinophilia, Pityriasis Lichenoides, post-transplant lymphoproliferative disorder, autoimmune lymphoproliferative syndrome (ALPS), Lymphoid interstitial pneumonia, Epstein Barr virus associated lymphoproliferative diseases, Castleman disease and X-linked lymphoproliferative disease.

Many patients are asymptomatic at the time of first presentation, with the diagnosis being made as an incidental finding after a routine medical examination or blood test, for example, complete blood count (CBC).

Definitive diagnosis is made on the characteristic lymphocyte morphology and immunophenotype usually from samples of peripheral blood ,bone marrow samples or lymph nodes.

The membrane receptor proteins (CD19, CD81, CD21 (complement receptor type2) and Leu-13(CD225)), form a complex (CD19 complex) on human B lymphocytes that has costimulatory activity for the antigen receptor, membrane IgM(mIgM) .The complex is unique among known membrane protein complexes of the immune system because its components represent different protein families, and can be expressed individually.

The biochemical mechanism by which the complex costimulates is not understood.CD19 has been shown to be a major substrate of a protein tyrosine kinase activated by mIgM, and tyrosine phosphorylated CD19 binds phosphatidylinositol 3-kinase (PI3-kinase), an enzyme that is required for the cellular activating effects of certain receptor tyrosine kinases. Thus, several biochemical pathways may be triggered by the CD21/CD19/CD81/CD225 complex that relate to its role in amplifying the response of B cells to antigen.

Multiple biologic effects of the CD21/CD19/ CD81/CD225 complex may reflect the discrete actions of individual components, each of which is a member of a distinct protein family: CD21 of the regulators of complement activation family; CD19 of the Ig superfamily;and CD81 of the tetraspan family of membrane proteins and is an important regulator of B-cell signaling. CD225 of Interferon-induced transmembrane protein (IFITM) family.

Although CD19 function may be elicited following its potential binding to an as yet unidentified ligand, C3d binding to CD21 supplies an already characterized ligand for the CD19 complex, thereby linking complement immune responses and the generation of immunological activation and B cell function.

Ligation of members of the CD19 complex initiates a cascade of biological responses that can modulate signal transduction through the B cell Ag-receptor complex and other cell surface receptors. So it may help in understanding the signal transduction pathways through this complex.

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Study Type : Observational
Estimated Enrollment : 92 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Expression of CD19 Complex in Lymphoproliferative Disorders
Estimated Study Start Date : March 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : April 2023

Intervention Details:
  • Diagnostic Test: Flow cytometry
    The study of CD19 complex expression in lymphoproliferative disorders by flowcytometry


Primary Outcome Measures :
  1. To study the expression pattern of CD19 complex in lymphoproliferative disorders and its diagnostic value. [ Time Frame: Baseline ]
    Study of CD19 complex expression pattern in lymphoproliferative disorders by flow cytometry



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The sample size is 92 (46 in each arm) but number of controls will be decreased and number of cases will be increased.
Criteria

Inclusion Criteria:

  • Patients with acute lymphoproliferative disorders.
  • Patients with chronic lymphoproliferative disorders

Exclusion Criteria:

  • patients with non lymphoid disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04734470


Contacts
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Contact: Mahran Mohamed Hussein, Assistant Lecturer 01028444857 Mahran_Morsy@med.aun.edu.eg
Contact: Maged Salah Mahmoud, Prof. Dr 01011799677 m.mahmoud@aun.edu.eg

Sponsors and Collaborators
Assiut University
Publications:
Vaillant AAJ, Stang CM. Lymphoproliferative Disorders. StatPearls [Internet]: StatPearls Publishing; 2020.
van Zelm MC, Reisli I. CD19 Deficiency due to Genetic Defects in the CD19 and CD81 Genes. Humoral Primary Immunodeficiencies: Springer; 2019. p. 83-95.
Feingold JM, Ungar DR. DOSAGE REGIMES FOR THE ADMINISTRATION OF AN ANTI-CD19 ADC. US Patent App. 16/622,649; 2020.

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Responsible Party: Mahran mohamed hussein mahran, Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT04734470    
Other Study ID Numbers: Expression of CD19 complex
First Posted: February 2, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases