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Clinical Trials/NCT01057290
NCT01057290
Completed
Not Applicable

Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML

Children's Oncology Group0 sites75 target enrollmentSeptember 2012
ConditionsLeukemia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Children's Oncology Group
Enrollment
75
Primary Endpoint
Correlation of the Stat3 response category (constitutive, low-dose responsive, high-dose responsive, or unresponsive) with clinical data, including event-free and overall survival
Status
Completed
Last Updated
9 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
May 2016
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Correlation of the Stat3 response category (constitutive, low-dose responsive, high-dose responsive, or unresponsive) with clinical data, including event-free and overall survival

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