- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01298414
Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia
Pediatric Myeloid Leukemia-Specific miRNA Expression Profiles Induced by the Leukemic Stem Cell Niche
RATIONALE: Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.
PURPOSE: This research study is looking at biomarkers in bone marrow samples from young patients with acute myeloid leukemia.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- To study the effect of niche mesenchymal stromal cells (MSC) exposure on microRNAs (miR) expression in pediatric AML at different time points and compare those profiles to the miR profiles at baseline.
- To focus on four pediatric AML-specific miRs (miR34a, miR538e, miR193e, and miR198) which show the most significant differential expression after in vivo niche exposure at four months (hematogenous spread).
- To determine whether altered miR expression reflects or causes the metastatic invasion pattern of AML.
OUTLINE: Bone marrow-derived mesenchymal stromal cell (MSC) samples are implanted subcutaneously in NOD/SCID mice. Cells are then harvested at day 0, 1 month, and 4 months post-implantation. miRNA is isolated and analyzed by Ilumina MicroRNA Expression Profiling single Beadchip. The obtained data is then analyzed by the Illumina Genome Studio Analysis Software.
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- Diagnosis of acute myeloid leukemia
- Fresh human bone marrow samples obtained from orthopedic surgery at the Tissue Donation Program of The Feinstein Institute and the Children Oncology Group (COG) Myeloid Disease Biorepository
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment
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Exposure of AML cells to the niche MSCs generate changes in pediatric AML miR expression profiles
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Correlation between changes in pediatric AML miR expression profiles and changes in biological behavior of AML cells (dormant versus invasive)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah R.I. Vaiselbuh, MD, Feinstein Institute for Medical Research
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAML11B9 (Other Identifier: Children's Oncology Group)
- COG-AAML11B9 (Other Identifier: Children's Oncology Group)
- NCI-2011-02849 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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