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Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01229956
First received: October 27, 2010
Last updated: February 4, 2011
Last verified: February 2011
History of Changes

October 27, 2010
February 4, 2011
November 2010
January 2011   (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
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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 2011   (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
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NCT01229956
CDR0000687646, COG-AAML11B3
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Gregory H. Reaman, Children's Oncology Group - Group Chair Office
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
National Cancer Institute (NCI)
February 2011

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