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Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia

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ClinicalTrials.gov 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

October 27, 2010
October 28, 2010
May 19, 2016
November 2010
May 2016   (Final data collection date for primary outcome measure)
Identification of differential patterns of promoter hypermethylation and gene expression in pairwise comparisons with other cohorts and normal controls
Same as current
Complete list of historical versions of study NCT01229956 on ClinicalTrials.gov Archive Site
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Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia
Promoter Methylation in MLL-Rearranged Childhood AML

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.


  • 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.

Observational Model: Case-Only
Time Perspective: Retrospective
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Retention:   Samples With DNA
Non-Probability Sample
Patients With Acute Myeloid Leukemia.
  • Genetic: DNA methylation analysis
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
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May 2016   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
1 Year to 18 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
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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 )
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Children's Oncology Group
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
Children's Oncology Group
May 2016