Clinical Trials Directory

Trials / Completed

CompletedNCT01245231

Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

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

Status
Completed
Phase
Study type
Observational
Enrollment
150 (estimated)
Sponsor
Children's Oncology Group · Network
Sex
All
Age
30 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

Interventions

TypeNameDescription
GENETICprotein expression analysis
GENETICwestern blotting
OTHERflow cytometry
OTHERlaboratory biomarker analysis
OTHERmedical chart review

Timeline

Start date
2010-05-01
Primary completion
2016-05-01
First posted
2010-11-22
Last updated
2016-05-18

Source: ClinicalTrials.gov record NCT01245231. Inclusion in this directory is not an endorsement.