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.
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.
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 group | Role | What they receive |
|---|---|---|
| patients with aberrant CD markers | by flowcytometry from hospital information system | |
| patients without aberrant CD markers | by flowcytometry from hospital information system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted16 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completionJan 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mervat Awad Mohamed Ibrahim, Assiut University
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of Aberrant CD Markers in Acute Leukemia:Retrospective Study in South Egypt Cancer Institute
- ClinicalTrials.gov ID
- NCT03743909
- Acronym / sponsor ID
- acute leukemia
- Conditions
- Acute Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- Jan 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To determine incidence of Expression of aberrant CD markers in acute leukemia in South Egypt .
- Correlation between this expression and outcome of the patient.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with aberrant CD markers | – | –by flowcytometry from hospital information system |
| patients without aberrant CD markers | – | –by flowcytometry from hospital information system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- acute leukemia patients
Key inclusion criteria (1 listed)
- All cases of acute leukemia in South Egypt Cancer Institute.
Key exclusion criteria (1 listed)
- Cases outside South Egypt Cancer Institute.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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.