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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01035307
First received: December 17, 2009
Last updated: May 4, 2015
Last verified: May 2015
  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 [ 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 ]

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
Estimated Primary Completion Date: January 2100 (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

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

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: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01035307     History of Changes
Other Study ID Numbers: AAML09B2, COG-AAML09B2, CDR0000659560, NCI-2011-02201
Study First Received: December 17, 2009
Last Updated: May 4, 2015
Health Authority: United States: Federal Government

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, Acute
Leukemia, Myeloid
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on July 01, 2015