Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia
|ClinicalTrials.gov Identifier: NCT01245231|
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : May 18, 2016
RATIONALE: Studying samples of blood or tumor 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 patients will respond to treatment.
PURPOSE: This research study is studying prognostic biomarkers in cell samples from young patients with acute myeloid leukemia.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: protein expression analysis Genetic: western blotting Other: flow cytometry Other: laboratory biomarker analysis Other: medical chart review|
- To determine the percentage of primary acute myeloid leukemia (AML) samples with increased Stat3 signaling pathway 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 and the upstream and downstream regulators of Stat3 activation.
- To classify samples according to a Stat3 activation pattern and correlate this result with event-free survival (EFS) and overall survival (OS).
OUTLINE: Cryopreserved AML specimens are analyzed for pStat3 and pStat5 levels, response to cytokine levels, and expression level of proteins known to influence stat activity by flow cytometry and western blot assays. Results are also compared with prognostic variables determined in CCG-291 study, including age, race, WBC, and cytogenetic risks.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Stat3 Activation as a Potential Prognostic Marker and Therapeutic Target in Pediatric AML-II|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||May 2016|
- Correlation of constitutive pStat3 with inducible pStat3
- Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses
- Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression
- Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1
- Correlation between pStat3/pStat5 and event-free survival and overall survival
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245231
|Principal Investigator:||Michele S. Redell, MD, PhD||Texas Children's Cancer Center|