DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT00897936|
Recruitment Status : Completed
First Posted : May 12, 2009
Last Update Posted : May 19, 2017
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.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: DNA methylation analysis Genetic: comparative genomic hybridization Genetic: fluorescence in situ hybridization Genetic: microarray analysis Genetic: polymerase chain reaction Other: diagnostic laboratory biomarker analysis Other: immunologic technique|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||418 participants|
|Official Title:||A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL|
|Actual Study Start Date :||March 23, 2006|
|Primary Completion Date :||April 23, 2006|
|Study Completion Date :||April 23, 2006|
- Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile [ Time Frame: 1 day ]
- Relatedness on a per-gene basis of cross-platform data [ Time Frame: 1 day ]
- Ability of supervised clustering to distinguish subgroups according to clinical prognostic and biomarker indicators [ Time Frame: 1 day ]
- Ability of unsupervised clustering to identify subgroups of NCL patients [ Time Frame: 1 day ]
- Relative power of each platform mentioned above vs the integrated platforms [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897936
|Study Chair:||Ari M. Melnick, MD||Albert Einstein College of Medicine, Inc.|