Studying Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia Previously Enrolled on Clinical Trial POG-9421

May 17, 2016 updated by: Children's Oncology Group

Genomic and Proteomic Profiling of Childhood AML

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.

PURPOSE: This research study is looking at biomarkers in tissue samples from young patients with acute myeloid leukemia previously enrolled on clinical trial POG-9421.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • To profile basal and potentiated phospho-protein networks (PPPNs) using tissue samples from pediatric patients with de novo acute myeloid leukemia (AML) previously enrolled on clinical trial POG-9421.
  • To classify AML-based signal transduction mechanisms.
  • To correlate profiles of basal and PPPNs with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and profiles of gene expression in tumor tissue samples.

OUTLINE: Banked tissue samples are collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.

Study Type

Observational

Enrollment (Anticipated)

90

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Previously enrolled on POG 9421

Description

DISEASE CHARACTERISTICS:

  • Diagnosis of acute myeloid leukemia, meeting 1 of the following criteria:

    • Primary induction failure (i.e., failed to achieve remission within the first 60 days of therapy)
    • Relapsed disease (early or late)
    • In continuous complete remission
  • Previously enrolled on POG-9421
  • Tissue samples available

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Genomic and Proteomic Profiling
Genetic: gene expression analysis
Other: laboratory biomarker analysis
Genetic: proteomic profiling
Genetic: microarray analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples
Classification of AML-based signal transduction mechanisms
Correlation of basal and PPPN profiles with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBα, PASGΔ75, and karyotype) and gene expression profiles.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Norman J. Lacayo, MD, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Estimate)

May 18, 2016

Last Update Submitted That Met QC Criteria

May 17, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAML09B2
  • COG-AAML09B2 (Other Identifier: Children's Oncology Group)
  • CDR0000659560 (Other Identifier: NCI)
  • NCI-2011-02201 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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