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Biomarkers in Tissue 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: October 27, 2010
Last updated: May 17, 2016
Last verified: May 2016

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 Intervention
Genetic: DNA methylation analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Promoter Methylation in MLL-Rearranged Childhood AML

Resource links provided by NLM:

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

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

Biospecimen Retention:   Samples With DNA

Estimated Enrollment: 32
Study Start Date: November 2010
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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.


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

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 )
Study First Received: October 27, 2010
Last Updated: May 17, 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
Neoplasms processed this record on April 25, 2017