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