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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01035307
First received: December 17, 2009
Last updated: April 23, 2010
Last verified: April 2010
  Purpose

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.


Condition Intervention
Leukemia
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: proteomic profiling
Other: laboratory biomarker analysis

Study Type: Observational
Official Title: Genomic and Proteomic Profiling of Childhood AML

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 90
Study Start Date: October 2009
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01035307

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Norman J. Lacayo, MD Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Norman J. Lacayo, Stanford Cancer Center
ClinicalTrials.gov Identifier: NCT01035307     History of Changes
Other Study ID Numbers: CDR0000659560, COG-AAML09B2
Study First Received: December 17, 2009
Last Updated: April 23, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on October 01, 2014