Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01229956
First received: October 27, 2010
Last updated: May 11, 2015
Last verified: May 2015

October 27, 2010
May 11, 2015
November 2010
January 2100   (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 [ Designated as safety issue: No ]
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.

OBJECTIVES:

  • 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
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Tissue

Non-Probability Sample

Patients With Acute Myeloid Leukemia.

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.
 
Active, not recruiting
32
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January 2100   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
1 Year to 18 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01229956
AAML11B3, COG-AAML11B3, NCI-2011-02842, AAML11B3
No
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 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP