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Acute LeukemiaNCT03743909

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

An observational study of Acute Leukemia, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Acute Leukemia
How many people
100 participants
Where
No sites listed yet
Study dates
1 Jan 2019to Apr 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: acute leukemia patients

Who may be able to join

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

Who cannot join

  • Cases outside South Egypt Cancer Institute.

Trial locations and contacts

No sites are listed yet.

mervat A mohamed contact

01011893938

mervatawad67@yahoo.com

About this study

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

Conditions
Acute Leukemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03743909
Study groupRoleWhat they receive
patients with aberrant CD markersby flowcytometry from hospital information system
patients without aberrant CD markersby flowcytometry from hospital information system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Expression of aberrant CD markers in acute leukemia by flowcytometry : Retrospective study in South Egypt Cancer Institute

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

    Measured: 2008-2018

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Nov 2018
  2. Study start1 Jan 2019 (estimated)
  3. Primary completionJan 2021 (estimated)
  4. Study completionApr 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03743909
Sponsor's protocol ID
acute leukemia
Status last verified
Nov 2018
First submitted
14 Nov 2018
Last updated
16 Nov 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Leukemia, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact mervat A mohamed (01011893938, mervatawad67@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Expression of aberrant CD markers in acute leukemia by flowcytometry : Retrospective study in South Egypt Cancer Institute (time frame: 2008-2018). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2018.

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