MedPath

DNA Analysis of Tumor Tissue From Patients With Acute Myeloid Leukemia

Completed
Conditions
Leukemia
Registration Number
NCT00897936
Lead Sponsor
ECOG-ACRIN Cancer Research Group
Brief 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
418
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Relatedness on a per-gene basis of cross-platform data1 day
Nucleophosmin exon 12 mutation-related normal cytogenetics leukemia (NCL) has a specific genetic and epigenetic profile1 day
Ability of supervised clustering to distinguish subgroups according to clinical prognostic and biomarker indicators1 day
Ability of unsupervised clustering to identify subgroups of NCL patients1 day
Relative power of each platform mentioned above vs the integrated platforms1 day
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath