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Clinical Trials/NCT01059734
NCT01059734
Completed
Not Applicable

Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)

SWOG Cancer Research Network0 sites357 target enrollmentJune 2010
ConditionsLeukemia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
SWOG Cancer Research Network
Enrollment
357
Primary Endpoint
Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 2010
End Date
June 2012
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms

Time Frame: immediate

Distributions of mutations in TOP2 phosphorylation sites

Time Frame: immediate

Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival

Time Frame: immediate

Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics

Time Frame: immediate

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