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Completed

NCT Number: NCT01434329

S8600-S9031-S9333-A, Study of DNA in Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of blood and 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. It may also help doctors predict how patients respond to treatment.

PURPOSE: This research trial studies DNA in samples from patients with acute myeloid leukemia.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

OBJECTIVES:

  • To identify differentially methylated regions (DMRs) associated with overall survival (OS) of acute myeloid leukemia (AML) patients with normal cytogenetics.
  • To develop and evaluate in an independent validation set a prognostic score for OS based on the identified DMR.
  • To determine whether the prognostic score can group patients into risk groups based on OS.

OUTLINE: Archived blood or bone marrow samples are analyzed for DNA methylation alterations by CHARM array-based genome assay. Each patient's clinical data is also collected.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • De novo acute myeloid leukemia (AML) patients with normal cytogenetics treated with curative therapy who survived at least 28 days after therapy started
  • Samples will be taken from the following studies: SWOG-8600, SWOG-9031, SWOG-9333, SWOG-9500, SWOG-S9918, SWOG-S0106, and SWOG-S0112
  • Blood or marrow specimens can be used

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Treatment and study plan

DNA methylation analysis

Genetic

gene expression analysis

Genetic

microarray analysis

Genetic

laboratory biomarker analysis

Other

medical chart review

Other

Primary outcomes

  1. Identification of DMRs associated with OS

    Time frame: immediate

  2. Development and evaluation of a prognostic score of OS based on DMRs identified

    Time frame: immediate

  3. Prognostic score able to group AML patients into risk groups

    Time frame: immediate

Sponsors and collaborators

Lead sponsor

SWOG Cancer Research Network

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

S8600-S9031-S9333-A, Identification of Differentially Methylated Genomic Regions That Are Prognostically Significant in AML

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Sep 14, 2011
Registry last updated
Apr 15, 2016

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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