Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

Completed

• Conditions: Leukemia

• Registration Number: NCT01245231
• Lead Sponsor: Children's Oncology Group

Brief 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.

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-11-19
• Study First Submitted QC: 2010-11-19
• Study First Posted: 2010-11-22
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation of pStat3- and pStat5-induced responses with surface G-CSFR and gp130 expression
Correlation of pStat3 responses with pStat5 responses, and G-CSF-induced responses with IL-6- induced responses
Correlation of constitutive pStat3 with inducible pStat3
Correlation of constitutive pStat3/pStat5 with levels of the negative regulators SOCS3 and SHP1

Secondary Outcome Measures

Name	Time	Method
Correlation between pStat3/pStat5 and event-free survival and overall survival