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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01059734
First received: January 29, 2010
Last updated: January 13, 2014
Last verified: January 2014

January 29, 2010
January 13, 2014
June 2010
June 2012   (final data collection date for primary outcome measure)
  • Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Distributions of mutations in TOP2 phosphorylation sites [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms [ Designated as safety issue: No ]
  • Distributions of mutations in TOP2 phosphorylation sites [ Designated as safety issue: No ]
  • Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival [ Designated as safety issue: No ]
  • Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01059734 on ClinicalTrials.gov Archive Site
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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)

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.

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.

Observational
Time Perspective: Retrospective
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Non-Probability Sample

patients enrolled on S0931, S9126, S9333 or S9500 consenting to use of specimens for future research

Leukemia
  • Genetic: DNA analysis
  • Genetic: RNA analysis
  • Genetic: mutation analysis
  • Genetic: polymerase chain reaction
  • Genetic: polymorphism analysis
  • Other: laboratory biomarker analysis
Not Provided
Medeiros BC, Othus M, Estey EH, Fang M, Appelbaum FR. Unsuccessful diagnostic cytogenetic analysis is a poor prognostic feature in acute myeloid leukaemia. Br J Haematol. 2014 Jan;164(2):245-50. doi: 10.1111/bjh.12625. Epub 2013 Oct 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
357
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01059734
CDR0000664320, S9031-S9126-S9333-S9500-B, U10CA032102
No
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Anjali Advani, MD The Cleveland Clinic
Southwest Oncology Group
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP