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Biomarker Changes in Samples From Young Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01139931
First Posted: June 9, 2010
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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.


Condition Intervention
Leukemia Genetic: DNA methylation analysis Genetic: gene expression analysis Genetic: microarray analysis Genetic: polymorphism analysis Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Epigenetic Alterations in AML

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Relationships between genetic and epigenetic landscapes in AML

Estimated Enrollment: 15
Study Start Date: October 2009
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of acute myeloid leukemia
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01139931


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Soheil Meshinchi, MD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01139931     History of Changes
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) )
First Submitted: June 8, 2010
First Posted: June 9, 2010
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia/other myeloid malignancies

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