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

NCT ID: NCT01057290

Last Updated: 2016-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Leukemia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Interventions

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gene expression analysis

Intervention Type GENETIC

protein expression analysis

Intervention Type GENETIC

fluorescence activated cell sorting

Intervention Type OTHER

immunologic technique

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of pediatric acute myeloid leukemia

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michele S. Redell, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Children's Cancer Center

Other Identifiers

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COG-AAML10B16

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000664194

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-02206

Identifier Type: REGISTRY

Identifier Source: secondary_id

AAML10B16

Identifier Type: -

Identifier Source: org_study_id

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