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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT01434329
First received: September 13, 2011
Last updated: December 23, 2013
Last verified: December 2013
  Purpose

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 Intervention
Leukemia
Genetic: DNA methylation analysis
Genetic: gene expression analysis
Genetic: microarray analysis
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: S8600-S9031-S9333-A, Identification of Differentially Methylated Genomic Regions That Are Prognostically Significant in AML

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • Identification of DMRs associated with OS [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Development and evaluation of a prognostic score of OS based on DMRs identified [ Time Frame: immediate ] [ Designated as safety issue: No ]
  • Prognostic score able to group AML patients into risk groups [ Time Frame: immediate ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434329

Sponsors and Collaborators
Southwest Oncology Group
Investigators
Principal Investigator: Min Fang, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT01434329     History of Changes
Other Study ID Numbers: CDR0000710926, S8600-S9031-S9333-A, U10CA032102
Study First Received: September 13, 2011
Last Updated: December 23, 2013
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on September 30, 2014