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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
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
RNA analysis
Geneticmutation analysis
Geneticpolymerase chain reaction
Geneticpolymorphism analysis
Geneticlaboratory biomarker analysis
OtherPrimary 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
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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