FoxO3a and PU.1 in Acute Lymphoblastic Leukemia

February 5, 2023 updated by: MRA Youb, Assiut University

Value of FoxO3a and PU.1 Expression in Pediatric Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia (ALL) is one of the four major types of leukemia which is common in both children and adolescents; however, it is the most common pediatric malignancy diagnosed in children younger than 20 years .The disease pathogenesis results from blockade at any stages of normal lymphoid differentiation with uncontrolled proliferation of lymphoid cells. According to the World Health Organization (WHO) definition, ALL is categorized in B-Lymphoblastic Leukemia (B-ALL) And T-Lymphoblastic Leukemia (T-ALL), originated from B- and T-Lineage lymphoid precursor cells, respectively.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Proto-oncogenes and tumor suppressor genes are the most important genes involved in leukemogenesis , which their alterations disrupt normal regulatory processes such as self-renewal, proliferation, differentiation and apoptosis in target cells. Among those genes FoxO3a gene and PU.1 gene.

FoxO(Fork head box ,class O) transcription factors function as a tumor suppressor gene and are important for stem cell maintenance.They are key regulators of the cellular differentiation, growth, survival, cell cycle, metabolism, and cellular stress. There are four members of the foxO transcription factors in humans : foxO1, foxO3a, foxO4, foxO6 .FoxO3a is expressed in various tissues including B - and T-lymphoid cells. Over expression of FoxO3a in B and T cell lines induces cell cycle arrest in G1 phase , so it inhibits cell proliferation . FoxO3a is an important target of PI3K/AKT signaling pathway,which is hyperactivated in various types of cancers .Hyperactivation of this pathway in leukemia leads to inactivation of foxO3a in leukemic cells and enhances tumor growth .

PU .1(Purine-rich box 1) is a member of the E26 transformation-specific (ETS) Family . Normal hematopoiesis is securely controlled by asmall number of lineage-specific transcription factors, so that the disturbed expression or function of this group may be involved in the development of leukemia . PU.1 plays an important role in hematopiotic stem cell (HSC) self renewal and in myeloid and B-lymphoid differentiation. It controls the expression of several genes involved in hematopoiesis.

Study Type

Observational

Enrollment (Anticipated)

53

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

  • cases

    1. inclusion criteria: children aged 2-17 years and diagnosed as new cases of acute lymphoblastic leukemia

    2. exclusion criteria:

      1. age more than 17 years
      2. presence of other hematological disorders, history of other malignancies ,or relapsed ALL
      3. patients under chemotherapy or radiotherapy
  • controls (healthy age- and sex-matched children without ahistory of any malignancies)

Description

Inclusion Criteria:

  • children aged 2-17 years and diagnosed as new cases of acute lymphoblastic leukemia

Exclusion Criteria:

  1. age more than 17 years
  2. presence of other hematological disorders, history of other malignancies ,or relapsed ALL
  3. patients under chemotherapy or radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
study group
children aged 2-17 years and diagnosed as new cases of acute lymphoblastic leukemia
Other: complete blood count
  1. total RNA is isolated from fresh blood samples
  2. RNA is converted into complementary DNA c.DNA
  3. cDNA is then analysed by quantitatine Real Time PCR(qRT-PCR) to evaluate the relative expression levels of FoxO3a, PU.1 genes and TATA-binding protein (TBP) ,as an endogenous control gene.
Other Names:
  • bone marrow aspirate
control group
healthy age- and sex-matched children without ahistory of any malignancies
Other: complete blood count
  1. total RNA is isolated from fresh blood samples
  2. RNA is converted into complementary DNA c.DNA
  3. cDNA is then analysed by quantitatine Real Time PCR(qRT-PCR) to evaluate the relative expression levels of FoxO3a, PU.1 genes and TATA-binding protein (TBP) ,as an endogenous control gene.
Other Names:
  • bone marrow aspirate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
FoxO3a and PU.1 levels in acute lymphoblastic leukemia
Time Frame: 2 years
detection of the mean difference in FoxO3a and PU.1 expression levels between cases and controls
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

August 1, 2023

Primary Completion (ANTICIPATED)

March 30, 2024

Study Completion (ANTICIPATED)

December 30, 2024

Study Registration Dates

First Submitted

September 14, 2019

First Submitted That Met QC Criteria

September 14, 2019

First Posted (ACTUAL)

September 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 5, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • madonna

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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