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NCT Number: NCT01035307

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

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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

Up to 20 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene expression analysis

Genetic

microarray analysis

Genetic

proteomic profiling

Genetic

laboratory biomarker analysis

Other

Primary outcomes

  1. Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples

  2. Classification of AML-based signal transduction mechanisms

  3. 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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genomic and Proteomic Profiling of Childhood AML

Important dates

Study start
2009
Primary completion
2016
First posted
Dec 18, 2009
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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