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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01035307
First received: December 17, 2009
Last updated: May 17, 2016
Last verified: May 2016

December 17, 2009
May 17, 2016
October 2009
May 2016   (final data collection date for primary outcome measure)
  • Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples [ Designated as safety issue: No ]
  • Classification of AML-based signal transduction mechanisms [ Designated as safety issue: No ]
  • 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. [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035307 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Studying Biomarkers in Tissue Samples From Young Patients With Acute Myeloid Leukemia Previously Enrolled on Clinical Trial POG-9421
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Retention:   Samples Without DNA
Description:
Collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.
Non-Probability Sample
Previously enrolled on POG 9421
Leukemia
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: proteomic profiling
  • Other: laboratory biomarker analysis
Genomic and Proteomic Profiling
Interventions:
  • Genetic: gene expression analysis
  • Genetic: microarray analysis
  • Genetic: proteomic profiling
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
90
Not Provided
May 2016   (final data collection date for primary outcome measure)

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
Both
up to 20 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01035307
AAML09B2, COG-AAML09B2, CDR0000659560, NCI-2011-02201
No
Not Provided
Not Provided
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Norman J. Lacayo, MD Stanford University
Children's Oncology Group
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP