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Biomarkers in Young Patients With Acute Myeloid Leukemia

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01138332
First received: June 4, 2010
Last updated: June 5, 2010
Last verified: June 2010
History of Changes
  Purpose

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about biomarkers related to cancer.

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


Condition Intervention
Leukemia
 Genetic: western blotting
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Stat3 Signaling Pathway Aberrancies in Pediatric AML

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Correlations between levels of pY-Stat3 and levels of upstream cytokine receptors [ Designated as safety issue: No ]
  • Association of constitutive and/or increased pY-Stat3 and c-kit genotype [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: September 2009
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

  • Determine the frequency of ligand-independent phosphorylation of Stat3 in a small cohort of samples from pediatric patients with acute myeloid leukemia including, but not limited to, samples known to express mutated c-kit.
  • Measure the level of Stat3 phosphorylation in these samples after stimulation of three key cytokine receptors expressed on hematopoietic cells IL-6R, G-CSFR, and c-kit.

OUTLINE: Cryopreserved samples are analyzed for levels of various components of the Stat3 pathway via western blotting.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia

  • One of the following karyotypes:

    • t(8;21) and WT c-kit
    • t(8;21) and mutant c-kit
    • Normal karyotype

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01138332

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Michele S. Redell, MD, PhD Texas Children's Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Gregory H. Reaman, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01138332     History of Changes
Other Study ID Numbers: CDR0000671489, COG-AAML10B10
Study First Received: June 4, 2010
Last Updated: June 5, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute myeloid leukemia/other myeloid malignancies

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

ClinicalTrials.gov processed this record on May 19, 2013