Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: October 27, 2010
Last updated: May 11, 2015
Last verified: May 2015

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 [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA


Estimated Enrollment: 32
Study Start Date: November 2010
Estimated Primary Completion Date: January 2100 (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
Genders Eligible for Study:   Both
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
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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

Additional Information:
No publications provided

Responsible Party: Children's Oncology Group Identifier: NCT01229956     History of Changes
Other Study ID Numbers: AAML11B3, COG-AAML11B3, NCI-2011-02842, AAML11B3
Study First Received: October 27, 2010
Last Updated: May 11, 2015
Health Authority: United States: Federal Government

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, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type processed this record on October 08, 2015