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Biomarkers in Bone Marrow Samples From Young Patients With Acute Myeloid Leukemia

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: February 16, 2011
Last updated: May 17, 2016
Last verified: May 2016

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.

Condition Intervention
Leukemia Genetic: RNA analysis Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pediatric Myeloid Leukemia-Specific miRNA Expression Profiles Induced by the Leukemic Stem Cell Niche

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment
  • Exposure of AML cells to the niche MSCs generate changes in pediatric AML miR expression profiles
  • Correlation between changes in pediatric AML miR expression profiles and changes in biological behavior of AML cells (dormant versus invasive)

Biospecimen Retention:   Samples With DNA
Bone Marrow

Estimated Enrollment: 20
Study Start Date: February 2011
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of acute myeloid leukemia


  • 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


  • Not specified


  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01298414

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Sarah R.I. Vaiselbuh, MD Feinstein Institute for Medical Research
  More Information

Responsible Party: Children's Oncology Group Identifier: NCT01298414     History of Changes
Other Study ID Numbers: AAML11B9
COG-AAML11B9 ( Other Identifier: Children's Oncology Group )
NCI-2011-02849 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AAML11B9 ( Other Identifier: Children's Oncology Group )
Study First Received: February 16, 2011
Last Updated: May 17, 2016

Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia/other myeloid malignancies

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms processed this record on September 21, 2017