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OpenTrials
Completed

NCT Number: NCT01059734

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia
  • All subtypes allowed (except acute promyelocytic leukemia [M3])
  • Previously untreated OR relapsed/refractory disease
  • Isolated RNA specimens from bone marrow aspirate samples available from patients who participated on SWOG-9031, SWOG-9333 (cytarabine/daunorubicin hydrochloride induction arm only), SWOG-9500, or SWOG-9126

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

DNA analysis

Genetic

RNA analysis

Genetic

mutation analysis

Genetic

polymerase chain reaction

Genetic

polymorphism analysis

Genetic

laboratory biomarker analysis

Other

Primary outcomes

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

    Time frame: immediate

  2. Distributions of mutations in TOP2 phosphorylation sites

    Time frame: immediate

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

    Time frame: immediate

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

    Time frame: immediate

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 1, 2010
Registry last updated
Mar 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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