Prognostic Biomarkers in Samples From Young Patients With Acute Myeloid Leukemia

NCT ID: NCT01245231

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

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Brief Summary

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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

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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

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Leukemia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

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protein expression analysis

Intervention Type GENETIC

western blotting

Intervention Type GENETIC

flow cytometry

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

medical chart review

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Diagnosis of acute myeloid leukemia (AML)
* Cryopreserved AML specimens

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Maximum Eligible Age

30 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-AAML11B6

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000689410

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2011-02845

Identifier Type: REGISTRY

Identifier Source: secondary_id

AAML11B6

Identifier Type: -

Identifier Source: org_study_id

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