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S9031-S9126-S9333-S9500-B Biomarker Expression in Patients With Acute Myeloid Leukemia

Completed
Conditions
Leukemia
Registration Number
NCT01059734
Lead Sponsor
SWOG Cancer Research Network
Brief Summary

RATIONALE: Studying samples of bone marrow 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 biomarker expression in bone marrow samples from patients with acute myeloid leukemia.

Detailed Description

OBJECTIVES:

* Estimate the distributions of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms (SNPs) in patients with newly diagnosed acute myeloid leukemia (AML).

* Estimate the distributions of mutations in TOP2 phosphorylation sites (by SNP analysis) in these patients.

* Investigate whether expression of TOP2 or mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in these patients.

* Test whether TOP2 expression correlates with complete remission rates, relapse-free survival, and overall survival of these patients.

* Conduct preliminary analyses to estimate the distributions of TOP2 expression and mutations in TOP2 phosphorylation sites (by SNP analysis) in patients with relapsed and/or refractory AML.

* Investigate whether expression of TOP2 and mutations in TOP2 phosphorylation sites vary with patient or disease characteristics in patients with relapsed and/or refractory AML.

* Test whether TOP2 expression and mutations in TOP2 phosphorylation sites differ between previously untreated and relapsed/refractory AML patients.

OUTLINE: This is a multicenter study.

Archived RNA specimens are analyzed for topoisomerase 2 transcriptional expression by quantitative real-time polymerase chain reaction (PCR) and for mutations within TOP2 phosphorylation sites by single nucleotide polymorphism analysis.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
357
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphismsimmediate
Distributions of mutations in TOP2 phosphorylation sitesimmediate
Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survivalimmediate
Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristicsimmediate
Secondary Outcome Measures
NameTimeMethod
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