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CompletedNCT01059734Updated Mar 6, 2015

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

An observational study in Leukemia, sponsored by SWOG Cancer Research Network. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-03-06.

Sponsored by SWOG Cancer Research Network · Observational

Study type
Observational
Time perspective
Retrospective
Enrollment
357
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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)
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 357 is above the median of 120 across 744 observational studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

SWOG Cancer Research Network is the lead sponsor of 328 studies on the registry; 37 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 17 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Eligibility 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
05

Study design

Time perspective
Retrospective
Enrollment
357 participants (actual)
Patient registry
No

Interventions

  • GeneticDNA analysis
  • GeneticRNA analysis
  • Geneticmutation analysis
  • Geneticpolymerase chain reaction
  • Geneticpolymorphism analysis
  • Otherlaboratory biomarker analysis
06

What researchers measure

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

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Medeiros BC, Othus M, Fang M, Appelbaum FR, Erba HP. Cytogenetic heterogeneity negatively impacts outcomes in patients with acute myeloid leukemia. Haematologica. 2015 Mar;100(3):331-5. doi: 10.3324/haematol.2014.117267. Epub 2014 Dec 19. PubMed 25527568 ↗
  • 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. PubMed 24383844 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 6, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01059734
Lead sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Feb 1, 2010
Start date
Jun 2010
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Mar 6, 2015

Study contacts

Anjali Advani, MD
principal investigator · The Cleveland Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.

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