Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

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Brief Title

Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia

Official Title

Observational - Rapid Identification of Leukemia Stem Cells Associated With AML1-ETO and Inv(16) Through Characterization of Oncogene-Induced Changes in Cell-Surface Antigen Profiles on Hematopoietic Stem Cells

Brief Summary

      This laboratory study is looking into biomarkers in samples from younger patients with acute
      myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory
      may help doctors learn more about changes that occur in DNA and identify biomarkers related
      to cancer
    

Detailed Description

      Study Subtype: Observational Observational Study Model: Case-control Time Perspective:
      Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Cryopreserved
      bone marrow samples Study Population Description: Patient samples with the AML1-ETO
      translocation and cytologically normal AML samples for controls Sampling Method:
      Non-Probability Sample

      OBJECTIVES:

      I. To address whether the mutation-specific cell-surface markers observed in murine system
      will allow the prospective isolation of leukemia stem cells (LSC) from human bone marrow
      samples that have the same cytogenetic abnormalities.

      II. To compare the incidence of leukemia in NSG mice that have received CD34+CD38 marker+
      cells to NSG mice that receive what are hypothesized to be normal cells (CD34+CD38
      marker-subset) from the same patient.

      OUTLINE:

      Samples and controls are sorted and re-sorted for CD34, CD38, and CD55 subsets by single-cell
      polymerase chain reaction (PCR) analysis, flow cytometry, and reverse-transcriptase PCR.
      Sorted cell subsets are then transplanted into NSG mice. Beginning 6 weeks after
      transplantation, peripheral blood samples are collected and analyzed for human lymphoid- and
      myeloid-lineage cells by fluorescence-activated cell sorting (FACS).
    


Study Type

Observational


Primary Outcome

Expression of the CD55 marker on CD34+CD38‐ cells


Condition

Childhood Acute Monoblastic Leukemia (M5a)

Intervention

laboratory biomarker analysis

Study Arms / Comparison Groups

 Observational
Description:  Samples and controls are sorted and re-sorted for CD34, CD38, and CD55 subsets by single-cell PCR analysis, flow cytometry, and reverse-transcriptase PCR. Sorted cell subsets are then transplanted into NSG mice. Beginning 6 weeks after transplantation, peripheral blood samples are collected and analyzed for human lymphoid- and myeloid-lineage cells by FACS.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

20

Start Date

August 2012


Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

          -  Frozen bone marrow aspirates obtained from childhood acute myeloid leukemia (AML)
             patients possessing defined cytogenetic mutations; AML1-ETO or inv(16)

          -  Samples of cytogenetically normal AML cases obtained from the University of Alabama at
             Birmingham (UAB) as controls
      

Gender

All

Ages

N/A - 30 Years

Accepts Healthy Volunteers

No

Contacts

Stephanie Heidemann, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01642121

Organization ID

AAML12B10

Secondary IDs

NCI-2012-01983

Responsible Party

Sponsor

Study Sponsor

Children's Oncology Group

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Stephanie Heidemann, MD, Principal Investigator, Children's Oncology Group


Verification Date

May 2016