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Expression of Aberrant CD Markers in Acute Leukemia:Retrospective Study in South Egypt Cancer Institute

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: NCT03743909
Recruitment Status : Not yet recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Mervat Awad Mohamed Ibrahim, Assiut University

Brief Summary:
  • To determine incidence of Expression of aberrant CD markers in acute leukemia in South Egypt .
  • Correlation between this expression and outcome of the patient.

Condition or disease
Acute Leukemia

Detailed Description:

"Acute leukemia" is defined by the World Health organization standards, in which greater than 20% of the cells in the bone marrow are blasts (Kabuto et al., 2006).

Acute leukemia is a cloned expansion of tumor cells in bone marrow, blood or other tissues. The acute leukemia is classified as acute myeloid leukemia (AML) due to defective differentiation of myeloid lineage or acute lymphoid leukemia (ALL) due to defective differentiation of lymphoid lineage(Olaniyi JA et al., 2011).

Leukemia is diagnosed by morphology and cytochemical examination of blast cells, immunophenotyping, cytogenetic and molecular genetics. (Hazarika M et al., 2015 ). immunophenotyping is mandatory for the diagnosis of hematolymphoid malignancies (Craig FE et al., 2008)

Immunophenotyping of leukemia cells plays crucial role in identification of leukemia cell line, assesment of maturation stage and finding possible aberrant antigens which in turn serves for individual treatment monitoring and detection of residual disease(Kahng J et al.,2008).

Immunophenotyping identifies cell surface/CD markers(cluster of differentiation), expressed at different stages of cell development, by applying monoclonal antibodies against them helps in the diagnosis and classification of leukemia. The morphologically similar blast cells can be easily differentiated by immunophenotyping on the basis of expression and different CD markers (Angelescu S et al.,2012).

Aberrant expression of CD markers has been observed in several cases of acute leukemia(Chang Y et al., 2011).

Aberrant phenotype is a phenomenon in which lymphoid-associated and other myeloid lineage markers expressed in myeloblasts or myeloid-associated markers expressed in lymphoblasts. Aberrant phenotype incidence has been reported in both ALL and AML with varying frequencies as high as 88%(Macedo A et al.,1995).

The aberrant phenotypes are classified into different types: co-expression of lymphoid-associated antigens or lineage infidelity; asynchronous antigen expression, in which early antigens are coexpressed with more mature ones; or antigen overexpression and existence of abnormal light scatter patterns(Gert Ossenkoppele et al., 2011).

Presence or absence of these aberrant markers may also be associated with poor or favorable prognosis(Alhan C et al., 2014).

Several studies have reported correlations of aberrantly expressed markers with clinical outcome in AML. For example, CD7 and CD25 expression has been associated with poor prognosis in normal karyotype AML(Cerny J et al.,2013) The IL3 receptor alfa (CD123) is overexpressed in 45% of AML patients, and this higher expression has also been associated with poor outcome (Riccioni R et al.,2002).

CD13 and CD33 are most frequently associated with aberrant myeloid expression in ALL (Hrusák O et al,2002).Studies indicate that aberrant immunophenotypic expression can decrease the time of remission and survival in children with ALL (Kurec et al., 1991).Aberrant expression of CD13 in ≥ 5% of blasts of adult patients with ALL is an adverse prognostic factor,that should be considered for more aggressive treatment(Dalal BI1 et al.,2014).

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Expression of Aberrant CD Markers in Acute Leukemia:Retrospective Study in South Egypt Cancer Institute
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Group/Cohort
patients with aberrant CD markers
by flowcytometry from hospital information system
patients without aberrant CD markers
by flowcytometry from hospital information system



Primary Outcome Measures :
  1. Expression of aberrant CD markers in acute leukemia by flowcytometry : Retrospective study in South Egypt Cancer Institute [ Time Frame: 2008-2018 ]
    • To determine incidence of Expression of aberrant CD markers in acute leukemia in South Egypt .
    • Correlation between this expression and outcome of the patient.



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:   No
Sampling Method:   Non-Probability Sample
Study Population
acute leukemia patients
Criteria

Inclusion Criteria:

  • All cases of acute leukemia in South Egypt Cancer Institute.

Exclusion Criteria:

  • Cases outside South Egypt Cancer Institute.

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): NCT03743909


Contacts
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Contact: mervat A mohamed 01011893938 mervatawad67@yahoo.com
Contact: douaa M sayed 01006261987 douaa_sayed@hotmail.com

Sponsors and Collaborators
Assiut University
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Responsible Party: Mervat Awad Mohamed Ibrahim, South Egypt cancer institute Assuit university, Assiut University
ClinicalTrials.gov Identifier: NCT03743909    
Other Study ID Numbers: acute leukemia
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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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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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Disease Attributes
Pathologic Processes