We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01298414
Recruitment Status : Completed
First Posted : February 17, 2011
Last Update Posted : May 19, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment
Leukemia Genetic: RNA analysis Other: laboratory biomarker analysis

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.

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Pediatric Myeloid Leukemia-Specific miRNA Expression Profiles Induced by the Leukemic Stem Cell Niche
Study Start Date : February 2011
Primary Completion Date : May 2016
Study Completion Date : May 2016

Primary Outcome Measures :
  1. miR expression patterns in pediatric AML are regulated by the niche MSC-associated microenvironment
  2. Exposure of AML cells to the niche MSCs generate changes in pediatric AML miR expression profiles
  3. 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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298414

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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov 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 )
First Posted: February 17, 2011    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 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