Trials / Completed
CompletedNCT01642121
Studying Biomarkers in Samples From Younger Patients With Acute Myeloid Leukemia
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 20 (actual)
- Sponsor
- Children's Oncology Group · Network
- Sex
- All
- Age
- 30 Years
- Healthy volunteers
- Not accepted
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).
Conditions
- Childhood Acute Monoblastic Leukemia (M5a)
- Childhood Acute Monocytic Leukemia (M5b)
- Childhood Acute Myeloblastic Leukemia Without Maturation (M1)
- Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
- Childhood Acute Myelomonocytic Leukemia (M4)
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2012-08-01
- Primary completion
- 2016-05-01
- First posted
- 2012-07-17
- Last updated
- 2016-05-19
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01642121. Inclusion in this directory is not an endorsement.