Biomarker Changes in Samples From Young Patients With Acute Myeloid Leukemia

May 17, 2016 updated by: Children's Oncology Group

Epigenetic Alterations in AML

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarker changes in samples from young patients with acute myeloid leukemia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Map key histone modifications and cytosine methylation in leukemia cell lines with defined oncogenic mutations.
  • Acquire genome-wide maps of key histone modifications and cytosine methylation for primary leukemia in samples from patients with acute myeloid leukemia (AML).
  • Investigate functional relationships between genetic and epigenetic landscapes in AML.

OUTLINE: Archived samples are analyzed in vivo and in vitro (cell line) for histone modification and cytosine methylation. Genome-wide locations of 5 histone modifications are analyzed using chip-Seq, as well as DNA methylation analysis at nucleotide-resolution by high-throughput bisulfite sequencing. These epigenetic data are correlated with genomic data (sequence analysis, expression array, SNP array).

Study Type

Observational

Enrollment (Anticipated)

15

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

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Diagnosis of acute myeloid leukemia

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia
  • Primary leukemia samples from the Children Oncology Group (COG) bank with sufficient number of cells (500,000-1 million cells) with > 80% of leukemia blasts

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified

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
Relationships between genetic and epigenetic landscapes in AML

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Soheil Meshinchi, MD, 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, 2009

Primary Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 8, 2010

First Submitted That Met QC Criteria

June 8, 2010

First Posted (Estimate)

June 9, 2010

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAML10B9
  • COG-AAML10B9 (Other Identifier: Children's Oncology Group)
  • CDR0000671474 (Other Identifier: Clinical Trials.gov)
  • NCI-2011-02225 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

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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