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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01434329
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : April 15, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

Brief Summary:

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.

Condition or disease Intervention/treatment
Leukemia Genetic: DNA methylation analysis Genetic: gene expression analysis Genetic: microarray analysis Other: laboratory biomarker analysis Other: medical chart review

Detailed Description:


  • 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.

Study Type : Observational
Actual Enrollment : 200 participants
Time Perspective: Retrospective
Official Title: S8600-S9031-S9333-A, Identification of Differentially Methylated Genomic Regions That Are Prognostically Significant in AML
Study Start Date : October 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients enrolled on S8600, S9031 or S9333 who consented to use of specimens for future research


  • 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


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01434329

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Min Fang, MD, PhD Fred Hutchinson Cancer Research Center

Responsible Party: Southwest Oncology Group Identifier: NCT01434329     History of Changes
Other Study ID Numbers: S8600-S9031-S9333-A
S8600-S9031-S9333-A ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: April 15, 2016
Last Verified: April 2016

Keywords provided by Southwest Oncology Group:
untreated adult acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Leukemia, Myeloid