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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Children's Oncology Group
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Presence of the AML1-ETO translocation
Study Overview
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:
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- — to 30 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Presence of the AML1-ETO translocation
Time Frame: Up to 6 months
Expression of the CD55 marker on CD34+CD38- cells
Time Frame: Up to 6 months
Secondary Outcomes
No secondary outcomes reported