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Studying Tissue and Blood Samples From Patients With Acute Myeloid Leukemia

2014-08-27 03:22:14 | BioPortfolio

Summary

RATIONALE: Studying samples of tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tissue and blood samples from patients with acute myeloid leukemia.

Description

OBJECTIVES:

- Determine the frequency of specific single-gene markers (i.e., FLT3 ITD, MLL PTD, NPM1, KIT, RAS, CEBPA, WT1, JAK2 mutations, aberrant BAALC, ERG, FLT3, MN1, and EVI1) over-expression and levels of promoter methylation of specific genes (e.g., ESR1, WIT1, P15, MYOD1, ID4, DPK) in defined cytogenetic subgroups of patients with acute myeloid leukemia (AML).

- Correlate these gene markers with clinical and laboratory parameters in these patients.

- Correlate these gene markers with clinical outcome (i.e., complete remission [CR], disease-free survival [DFS], cumulative incidence of relapse [CIR], and overall survival [OS]) in these patients.

- Identify specific microarray multi-gene expression signatures in these patients.

- Correlate specific microarray multi-gene expression signatures with clinical and laboratory parameters in these patients.

- Correlate specific microarray multi-gene expression signatures with clinical outcome (i.e., CR, DFS, CIR, and OS) in these patients.

- Identify specific microarray multi-microRNA (miR) expression signatures in these patients

- Correlate specific microarray multi-miR expression signatures with clinical and laboratory parameters in these patients.

- Correlate specific microarray multi-miR expression signatures with clinical outcome (i.e., CR, DFS, CIR, and OS) in these patients.

- Explore the relative contribution of prognostic gene markers (i.e., FLT3 ITD, MLL PTD, NPM1, KIT, RAS, CEBPA, WT1, and JAK2 mutations, and aberrant BAALC, ERG, FLT3, MN1, and EVI1 over-expression), levels of promoter methylation of specific genes (e.g., ESR1, WIT1, P15, MYOD1, ID4, DPK), and microarray gene and miR expression signatures in defined cytogenetic subgroups of AML.

- Determine changes in these molecular markers and microarray gene and miR expression signatures at CR and relapse and the influence that these changes have on subsequent clinical course.

- Correlate the relative level of nuclear pSTAT5 and pERK in bone marrow blasts with outcome (EFS, CR, DFS, OS).

OUTLINE: This is a multicenter study.

Procured and archived bone marrow aspirate samples, blood and buccal cell samples, and bone marrow biopsy slides are analyzed for FLT3 ITD, MLL PTD, NPM1, KIT, KRAS, NRAS, CEBPA, WT1, and JAK2 mutations, levels of BAALC, ERG, EVI1, and MN1, microarray gene-expression, microRNA gene-expression signature, levels of methylation of genes silenced in AML, and genomic DNA by PCR amplification, RT-PCR, and denaturing high-performance liquid chromatography.

Study Design

N/A

Conditions

Leukemia

Intervention

DNA analysis, DNA methylation analysis, gene expression analysis, mutation analysis, polymerase chain reaction, reverse transcriptase-polymerase chain reaction, high performance liquid chromatography, laboratory biomarker analysis

Location

Tunnell Cancer Center at Beebe Medical Center
Lewes
Delaware
United States
19958

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:22:14-0400

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