NCT01059734

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

Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 357 (actual)
• Sponsor: SWOG Cancer Research Network · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
GENETIC	DNA analysis
GENETIC	RNA analysis
GENETIC	mutation analysis
GENETIC	polymerase chain reaction
GENETIC	polymorphism analysis
OTHER	laboratory biomarker analysis

Timeline

• Start date: 2010-06-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2010-02-01
• Last updated: 2015-03-06