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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03712488
Other study ID # flow cytometry in neoplasms
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 15, 2018
Est. completion date April 1, 2021

Study information

Verified date October 2018
Source Assiut University
Contact menna M atef, resident
Phone 01025536683
Email menna.abdelaziz9193@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The investigator's goals in this study are to assess :

1. Differential expression of CD200 by using flow cytometric immune-phenotyping in broad range of patients with B-chronic lymphoproliferative disorders (B-CLPD)

2. Role of CD200 in diagnosis , classification and potential value in differential diagnosis

3. CD200 expression level at different anatomic sites


Description:

B-Chronic lymphoproliferative disorders (B-CLPDs) are heterogeneous group of disorders with variable clinical presentations and outcomes. They are classified into : chronic lymphocytic leukaemia (CLL), B‐cell prolymphocytic leukaemia (B‐PLL), hairy cell leukaemia (HCL), and mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), follicular lymphoma (FL) and lymphoplasmacytic lymphoma/WaldenstrÖm macroglobulinaemia (LPL/WM) in leukaemia phase.

Characterization of CLPDs by immunophenotyping (IPT) has become an important and widely used method in hematology. Immunophenotyping is indispensable for the diagnosis of B-CLPDs through recognition of restricted light chain expression and characteristic phenotypes of separate entities.

Immunophenotypic characterization of lymphoid neoplasms is important for diagnosis, sub-classification, and staging and can also play a role in monitoring minimal residual disease. However, the differential diagnosis may be difficult to resolve in some cases, for example, between B-cell neoplasms with full or partial CD5 expression.

CD200 has recently been identified as a potentially useful antigen for flow cytometric immunophenotyping of lymphoid neoplasms, particularly those of the B lineage.

CD200 belongs to the immunoglobulin superfamily and is composed of a light chain-like structure with two extracellular variable- and constant-like domains followed by a transmembrane segment and a cytoplasmic tail.5 CD200 is expressed by various cell types, including B cells, a subset of T cells (including activated T cells), thymocytes, endothelial cells, and neurons .

CD200 generates an immunosuppressive signal by binding to its cognate receptor, CD200 receptor 1 (CD200R1) , which is expressed specifically in granulocytes and monocytes and in a subset of T cells. CD200 appears to play a role in the regulation of antitumor activity and these findings are the basis for ongoing clinical trials using anti-CD200 therapy for chronic lymphocytic leukemia (CLL)


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date April 1, 2021
Est. primary completion date August 30, 2020
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- All newly diagnosed patients with B-chronic lymphoproliferative disorders

Exclusion Criteria:

- 1) Patient refusal 2) Patients diagnosed T-cell non-hodgkins lymphoma 3) Patients receiving chemo and/or radiotherapy 4) Patients on steroid therapy for any other cause 5) Patients receiving any immunosuppressive drugs

Study Design


Related Conditions & MeSH terms


Intervention

Device:
flowcytometry
four colour flowcytometry

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (5)

Baseggio L, Traverse-Glehen A, Petinataud F, Callet-Bauchu E, Berger F, Ffrench M, Couris CM, Thieblemont C, Morel D, Coiffier B, Salles G, Felman P. CD5 expression identifies a subset of splenic marginal zone lymphomas with higher lymphocytosis: a clinico-pathological, cytogenetic and molecular study of 24 cases. Haematologica. 2010 Apr;95(4):604-12. doi: 10.3324/haematol.2009.011049. Epub 2009 Dec 16. — View Citation

Challagundla P, Medeiros LJ, Kanagal-Shamanna R, Miranda RN, Jorgensen JL. Differential expression of CD200 in B-cell neoplasms by flow cytometry can assist in diagnosis, subclassification, and bone marrow staging. Am J Clin Pathol. 2014 Dec;142(6):837-44. doi: 10.1309/AJCPBV9ELXC0ECVL. — View Citation

Rygiel TP, Karnam G, Goverse G, van der Marel AP, Greuter MJ, van Schaarenburg RA, Visser WF, Brenkman AB, Molenaar R, Hoek RM, Mebius RE, Meyaard L. CD200-CD200R signaling suppresses anti-tumor responses independently of CD200 expression on the tumor. Oncogene. 2012 Jun 14;31(24):2979-88. doi: 10.1038/onc.2011.477. Epub 2011 Oct 24. — View Citation

Schlette E, Fu K, Medeiros LJ. CD23 expression in mantle cell lymphoma: clinicopathologic features of 18 cases. Am J Clin Pathol. 2003 Nov;120(5):760-6. — View Citation

Ugo V, Leporrier N, Salaun V, Letestu R, Radford-Weiss I, Ramond S, Nataf J, Guesnu M, Picard F, Brouzes C, Perrot JY, Valensi F, Levy V, Ajchenbaum-Cymbalista F, Troussard X. Deciphering leukemic B-cell chronic lymphoproliferative disorders. Leuk Lymphoma. 2006 Oct;47(10):2088-95. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Differential expression of CD200 by using flow cytometric immune-phenotyping in B-chronic lymphoproliferative disorders (B-CLPD) Analysis of expression of CD200 in B-CLPDs for differential diagnosis of subtypes of B-CLPDs baseline
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