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

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01035307
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 90

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Leukemia	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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Genomic and Proteomic Profiling of Childhood AML
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Genomic and Proteomic Profiling	Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: proteomic profiling; Other: laboratory biomarker analysis

Outcome Measures

Primary Outcome Measures

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. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 20 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

No locations specified.

Sponsors and Collaborators

• Children's Oncology Group
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Norman J. Lacayo, MD, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01035307
• Other Study ID Numbers: AAML09B2; COG-AAML09B2; CDR0000659560; NCI-2011-02201
• First Posted: Dec 18, 2009
• Last Update Posted: May 18, 2016
• Last Verified: May 1, 2016

• Keywords provided by Children's Oncology Group: childhood acute myeloid leukemia in remission; recurrent childhood acute myeloid leukemia
• Additional relevant MeSH terms: Leukemia

Study Results

No Results Posted as of May 18, 2016