Biomarker Study in Tissue Samples From 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: NCT01232842
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : July 11, 2016
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 identify and learn more about biomarkers related to cancer.

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

Condition or disease Intervention/treatment
Leukemia Genetic: cytogenetic analysis Other: HUMARA assay Other: fluorescence activated cell sorting Other: laboratory biomarker analysis

Detailed Description:


  • Determine the frequency of acute myeloid leukemia (AML) that originates in CD33+ precursors or in which uncontrolled growth is restricted to CD33+ precursors.

OUTLINE: Cryopreserved acute myeloid leukemia cell samples are separated from endothelial cell by fluorescent-activated cell sorting (FACS) and analyzed for X-chromosome inactivation patterns by cytogenetic/molecular analysis and/or Humara assay.

Study Type : Observational
Estimated Enrollment : 20 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Assessment of Stem Cell Heterogeneity in AML in Co-Culture Systems Using X Chromosome Inactivation Patterns
Study Start Date : October 2010
Actual Primary Completion Date : July 2016

Primary Outcome Measures :
  1. Frequency of AML that originate in CD33+ or in which uncontrolled growth is restricted to CD33+ precursors
  2. Extent of clonal hematopoiesis in small numbers of AML cells

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosed with acute myeloid leukemia.


  • Diagnosed with acute myeloid leukemia
  • Known CD34+ progenitor cells
  • Available freshly isolated, uncultured cell samples


  • 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): NCT01232842

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Roland Walter, MD, PhD Fred Hutchinson Cancer Research Center

Responsible Party: Children's Oncology Group Identifier: NCT01232842     History of Changes
Other Study ID Numbers: AAML11B4
COG-AAML11B4 ( Other Identifier: Children's Oncology Group )
NCI-2011-02843 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AAML11B4 ( Other Identifier: Children's Oncology Group )
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

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

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