NCT00897936

DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia

A Pilot Study to Characterize the Genomic and Epigenomic Signature of NPM Positive Vs. NPM Negative NCL

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 418 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-03-23
• Primary completion: 2009-10-15
• Completion: 2009-10-15
• First posted: 2009-05-12
• Last updated: 2020-07-31