Clinical Trials Directory

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

Interventions

TypeNameDescription
OTHERlaboratory biomarker analysisCorrelative 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.