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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:
ClinicalTrials.gov Identifier:
NCT01035307
First Posted: December 18, 2009
Last Update Posted: May 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  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
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Genomic and Proteomic Profiling of Childhood AML

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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.

Biospecimen Retention:   Samples Without DNA
Collected for laboratory studies, including phospho-protein signaling and gene expression profiling studies.

Estimated Enrollment: 90
Study Start Date: October 2009
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Genomic and Proteomic Profiling Genetic: gene expression analysis Genetic: microarray analysis Genetic: proteomic profiling Other: laboratory biomarker analysis

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Previously enrolled on POG 9421
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01035307


Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Norman J. Lacayo, MD Stanford University
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01035307     History of Changes
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) )
First Submitted: December 17, 2009
First Posted: December 18, 2009
Last Update Posted: May 18, 2016
Last Verified: May 2016

Keywords provided by Children's Oncology Group:
childhood acute myeloid leukemia in remission
recurrent childhood acute myeloid leukemia

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