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

Leukemia Clinical Trial

Official title:

Genomic and Proteomic Profiling of Childhood AML

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01035307
• Other study ID #: AAML09B2
• Secondary ID: COG-AAML09B2CDR0
• Status: Completed
• Phase: N/A
• First received: December 17, 2009
• Last updated: May 17, 2016
• Start date: October 2009

Study information

• Verified date: May 2016
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid, Acute

Intervention

Genetic:
• gene expression analysis

• microarray analysis

• proteomic profiling

Other:
• laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profiling of basal and potentiated phospho-protein networks (PPPNs) using tissue samples			No
Primary	Classification of AML-based signal transduction mechanisms			No
Primary	Correlation of basal and PPPN profiles with specific molecular lesions (e.g., FLT3-ITD, NPM, WT1, c-kit, CEPBa, PASG?75, and karyotype) and gene expression profiles.			No

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database