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

April 14, 2016 updated by: Southwest Oncology Group

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

200

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 S8600, S9031 or S9333 who consented to use of specimens for future research

Description

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

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
Identification of DMRs associated with OS
Time Frame: immediate
immediate
Development and evaluation of a prognostic score of OS based on DMRs identified
Time Frame: immediate
immediate
Prognostic score able to group AML patients into risk groups
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: Min Fang, MD, PhD, Fred Hutchinson Cancer Center

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

October 1, 2011

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

September 13, 2011

First Submitted That Met QC Criteria

September 13, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S8600-S9031-S9333-A (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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