Biomarkers in Tissue 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. Identifier: NCT01229956
Recruitment Status : Completed
First Posted : October 28, 2010
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 tissue from patients with cancer the in laboratory may help doctors identify and 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: DNA methylation analysis Genetic: gene expression analysis Genetic: microarray analysis Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis

Detailed Description:


  • To determine whether the pattern of global and TSG-specific promoter CpG island hypermethylation and gene silencing that we have shown characterizes MLL-rearranged (MLL-r) infant bilineage ALL is also characteristic of other subsets of MLL-r leukemia.

OUTLINE: Previously collected cryopreserved cells from diagnosis are analyzed for promoter methylation via HELP arrays, gene expression arrays, and RT-qPCR.

PROJECTED ACCRUAL: A total of 32 samples (8 from each of 4 biologically defined cohorts) will be analyzed.

Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Promoter Methylation in MLL-Rearranged Childhood AML
Study Start Date : November 2010
Actual Primary Completion Date : May 2016

Primary Outcome Measures :
  1. Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Acute Myeloid Leukemia.


  • Available cryopreserved cells from diagnosis

    • At least 2 x 10^7 viably cryopreserved cells
  • One of the following biologically defined cytogenetics/molecular cohorts:

    • t(9;11)
    • t(11;19)
    • Other 11q23 translocations
    • Normal cytogenetics


  • 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): NCT01229956

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Patrick N. Brown, MD CHRISTUS Santa Rosa Cancer Center at CHRISTUS Santa Rosa Hospital - City Centre

Responsible Party: Children's Oncology Group Identifier: NCT01229956     History of Changes
Other Study ID Numbers: AAML11B3
COG-AAML11B3 ( Other Identifier: Children's Oncology Group )
NCI-2011-02842 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
AAML11B3 ( Other Identifier: Children's Oncology Group )
First Posted: October 28, 2010    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia
untreated childhood acute myeloid leukemia and other myeloid malignancies

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