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NCT01434329 Clinical Trial

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

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01434329
Other study ID # S8600-S9031-S9333-A
Secondary ID S8600-S9031-S933
Status Completed
Phase N/A
First received September 13, 2011
Last updated April 14, 2016
Start date October 2011
Est. completion date December 2015

Study information
Verified date April 2016
Source Southwest Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• DNA methylation analysis

• gene expression analysis

• microarray analysis

Other:
• laboratory biomarker analysis

• medical chart review

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Southwest Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of DMRs associated with OS immediate No
Primary Development and evaluation of a prognostic score of OS based on DMRs identified immediate No
Primary Prognostic score able to group AML patients into risk groups immediate No
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