Biomarkers in 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. Identifier: NCT01138332
Recruitment Status : Completed
First Posted : June 7, 2010
Last Update Posted : May 6, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from young patients with acute myeloid leukemia.

Condition or disease Intervention/treatment
Leukemia Genetic: western blotting Other: laboratory biomarker analysis

Detailed Description:


  • Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.
  • Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.

OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Stat3 Signaling Pathway Aberrancies in Pediatric AML
Study Start Date : September 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Primary Outcome Measures :
  1. Correlations between levels of pY-Stat3 and levels of upstream cytokine receptors
  2. Association of constitutive and/or increased pY-Stat3 and c-kit genotype

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 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
  • One of the following karyotypes:

    • t(8;21) and WT c-kit
    • t(8;21) and mutant c-kit
    • Normal karyotype


  • 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 identifier (NCT number): NCT01138332

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Michele S. Redell, MD, PhD Texas Children's Cancer Center

Responsible Party: Children's Oncology Group Identifier: NCT01138332     History of Changes
Other Study ID Numbers: AAML10B10
COG-AAML10B10 ( Other Identifier: Children's Oncology Group )
CDR0000671489 ( Other Identifier: Clinical )
NCI-2011-02226 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: June 7, 2010    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015

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

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid