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

March 5, 2015 updated by: Southwest Oncology Group

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

357

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distribution of topoisomerase 2 (TOP2) expression and single nucleotide polymorphisms
Time Frame: immediate
immediate
Distributions of mutations in TOP2 phosphorylation sites
Time Frame: immediate
immediate
Correlation of TOP2 expression with complete remission rates, relapse-free survival, and overall survival
Time Frame: immediate
immediate
Variation of TOP2 expression and mutations in TOP2 phosphorylation sites among patients and disease characteristics
Time Frame: immediate
immediate

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Southwest Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Anjali Advani, MD, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

January 29, 2010

First Submitted That Met QC Criteria

January 29, 2010

First Posted (Estimate)

February 1, 2010

Study Record Updates

Last Update Posted (Estimate)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S9031-S9126-S9333-S9500-B (Other Identifier: SWOG)
  • U10CA032102 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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