Leukemia Clinical Trial
Official title:
A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL
RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help
doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
It may also help doctors predict how well patients respond to treatment.
PURPOSE: This laboratory study is looking at tissue samples from patients with acute myeloid
leukemia.
OBJECTIVES:
Primary
- Determine gene expression, genome integrity, cytosine methylation, and chromatin
structure in patients with normal cytogenetics leukemia (NCL) acute myeloid leukemia.
- Determine whether NCL can be deconstructed into specific disease entities by analysis of
the integrated genomic and epigenomic datasets using supervised and unsupervised methods
in these patients.
- Identify the gene pathways that define NCL subtypes and molecular targets for validation
in preclinical and clinical trials for these patients.
- Determine whether integrated analysis provides markers of prognostic and therapeutic
response that accurately predicts clinical outcome and can be used to select patients
for risk-stratified therapeutic trials.
OUTLINE: This is a pilot, multicenter study.
Samples are analyzed to assess array comparative genomic hybridization using polymerase chain
reaction (PCR) and fluorescent in situ hybridization; chromatin immunoprecipitations (chip)
using PCR; Hpa II tiny fragment enrichment by ligation-mediated PCR (HELP) using DNA
methylation analysis; and gene expression profiling.
PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.
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