NCT01434329

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2011

Completed
17 days until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

4.2 years

First QC Date

September 13, 2011

Last Update Submit

April 14, 2016

Conditions

Leukemia

Keywords

untreated adult acute myeloid leukemia

Outcome Measures

Primary Outcomes (3)

  • Identification of DMRs associated with OS

    immediate

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

    immediate

  • Prognostic score able to group AML patients into risk groups

    immediate

Interventions

DNA methylation analysisGENETIC
gene expression analysisGENETIC
microarray analysisGENETIC
laboratory biomarker analysisOTHER
medical chart reviewOTHER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia

Interventions

DNA MethylationGene Expression ProfilingMicroarray Analysis

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

MethylationAlkylationBiochemical PhenomenaChemical PhenomenaMetabolismGenetic PhenomenaGenetic TechniquesInvestigative TechniquesMicrochip Analytical Procedures

Study Officials

  • Min Fang, MD, PhD

    Fred Hutchinson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2011

First Posted

September 14, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

April 15, 2016

Record last verified: 2016-04