Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia
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|ClinicalTrials.gov Identifier: NCT01057290|
Recruitment Status : Completed
First Posted : January 27, 2010
Last Update Posted : May 18, 2016
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|
- 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 Type :||Observational|
|Estimated Enrollment :||75 participants|
|Observational Model:||Case Control|
|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|
- 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
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
|Principal Investigator:||Michele S. Redell, MD, PhD||Texas Children's Cancer Center|