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Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia

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.
 
ClinicalTrials.gov Identifier: NCT01057290
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : May 18, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Study Description
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Brief Summary:

RATIONALE: Studying samples of tissue 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 well patients will respond to treatment.

PURPOSE: This research study is looking at biomarkers in cell samples from young patients with acute myeloid leukemia.


Condition or disease Intervention/treatment
Leukemia Genetic: gene expression analysis Genetic: protein expression analysis Other: fluorescence activated cell sorting Other: immunologic technique Other: laboratory biomarker analysis

Detailed Description:

OBJECTIVES:

  • To characterize Stat3 signaling pathway activity in primary tissue samples from pediatric patients with acute myeloid leukemia to determine the percentage of samples with increased activity and to better understand the mechanisms leading to increased activity.
  • To evaluate the presence of constitutive Stat3 activation and the sensitivity of Stat3 activation to low and high doses of cytokines.
  • To evaluate the expression levels of Stat3 protein as well as upstream and downstream regulators of Stat3 activation.
  • To classify tissue samples according to a Stat3-activation pattern, and to correlate this result with event-free survival and overall survival in order to determine whether increased Stat3 phosphorylation at diagnosis predicts poor outcome.

OUTLINE: Cryopreserved cell samples are collected for laboratory analysis, including immunoblotting, fluorescence activated cell sorting (FACS), and protein analysis.

Study Design
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Study Type : Observational
Estimated Enrollment : 75 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML
Study Start Date : September 2012
Actual Primary Completion Date : May 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Correlation of the Stat3 response category (constitutive, low-dose responsive, high-dose responsive, or unresponsive) with clinical data, including event-free and overall survival

Biospecimen Retention:   Samples With DNA
cell samples

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Diagnosis of pediatric acute myeloid leukemia
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of pediatric acute myeloid leukemia

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Contacts and Locations
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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): NCT01057290


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Michele S. Redell, MD, PhD Texas Children's Cancer Center
More Information
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Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01057290    
Other Study ID Numbers: AAML10B16
COG-AAML10B16 ( Other Identifier: Children's Oncology Group )
CDR0000664194 ( Other Identifier: Clinical Trials.gov )
NCI-2011-02206 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Posted: January 27, 2010    Key Record Dates
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:
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Leukemia
Neoplasms by Histologic Type
Neoplasms