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

Topoisomerase 2 Expression and Acute Myeloid Leukemia (AML)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01059734
Enrollment
357
Registered
2010-02-01
Start date
2010-06-30
Completion date
2012-06-30
Last updated
2015-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia

Keywords

adult acute myeloid leukemia with 11q23 (MLL) abnormalities, adult acute myeloid leukemia with del(5q), adult acute myeloid leukemia with inv(16)(p13;q22), adult acute myeloid leukemia with t(16;16)(p13;q22), adult acute myeloid leukemia with t(8;21)(q22;q22), recurrent adult acute myeloid leukemia, untreated adult acute myeloid leukemia, adult erythroleukemia (M6a), adult pure erythroid leukemia (M6b), adult acute monoblastic leukemia (M5a), adult acute monocytic leukemia (M5b), adult acute myeloblastic leukemia with maturation (M2), adult acute myeloblastic leukemia without maturation (M1), adult acute myelomonocytic leukemia (M4), secondary acute myeloid leukemia, adult acute minimally differentiated myeloid leukemia (M0), adult acute megakaryoblastic leukemia (M7)

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.

Interventions

GENETICDNA analysis
GENETICRNA analysis
GENETICmutation analysis
GENETICpolymerase chain reaction
GENETICpolymorphism analysis
OTHERlaboratory biomarker analysis

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
SWOG Cancer Research Network
Lead SponsorNETWORK

Study design

Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026