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NCT01057290 Clinical Trial

Studying Biomarkers in Cell Samples From Young Patients With Acute Myeloid Leukemia

Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01057290
Other study ID # AAML10B16
Secondary ID COG-AAML10B16CDR
Status Completed
Phase N/A
First received January 26, 2010
Last updated May 17, 2016
Start date September 2012

Study information
Verified date May 2016
Source Children's Oncology Group
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Both
Age group N/A to 18 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of pediatric acute myeloid leukemia

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Genetic:
• gene expression analysis

• protein expression analysis

Other:
• fluorescence activated cell sorting

• immunologic technique

• laboratory biomarker analysis

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Children's Oncology Group National Cancer Institute (NCI)

Outcome
Type Measure Description Time frame Safety issue
Primary Correlation of the Stat3 response category (constitutive, low-dose responsive, high-dose responsive, or unresponsive) with clinical data, including event-free and overall survival No
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