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

Completed

• Conditions: Leukemia
• Interventions: Genetic: gene expression analysis; Genetic: microarray analysis; Genetic: proteomic profiling; Other: laboratory biomarker analysis

• Registration Number: NCT01035307
• Lead Sponsor: Children's Oncology Group

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.

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 Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Last Update Submitted: 2016-05-17
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Genomic and Proteomic Profiling	laboratory biomarker analysis	-
Genomic and Proteomic Profiling	proteomic profiling	-
Genomic and Proteomic Profiling	microarray analysis	-
Genomic and Proteomic Profiling	gene expression analysis	-

Primary Outcome Measures

Name	Time	Method
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.