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Biomarkers in Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01138319
First Posted: June 7, 2010
Last Update Posted: May 6, 2015
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 from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in patients with acute myeloid leukemia.


Condition Intervention
Leukemia Genetic: DNA analysis Genetic: mutation analysis Genetic: polymerase chain reaction Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Mitochondrial Mutations and AML

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Association between clonally expanded somatic mitochondrial DNA mutations and acute myeloid leukemia

Biospecimen Retention:   Samples With DNA
blood samples

Enrollment: 18
Study Start Date: February 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • To determine whether clonally expanded somatic mitochondrial DNA mutations are associated with acute myeloid leukemia.

OUTLINE: Genomic DNA from blood samples obtained at diagnosis, remission, and relapse are analyzed for mitochondrial DNA mutations via PCR.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
  • Available blood samples from diagnosis, remission, and relapse

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): NCT01138319


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Jason H. Bielas, PhD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01138319     History of Changes
Other Study ID Numbers: AAML10B6
COG-AAML10B6 ( Other Identifier: Children's Oncology Group )
CDR0000671467 ( Other Identifier: Clinical Trials.gov )
NCI-2011-02224 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: June 4, 2010
First Posted: June 7, 2010
Last Update Posted: May 6, 2015
Last Verified: May 2015

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

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