Clinical Trial: Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis

Brief Summary: This pilot research trial studies biomarkers in bone marrow samples from pediatric patients with high risk acute myeloid leukemia. Studying samples of bone marrow from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).

II. To identify mutations, expression profile, gene copy number, loss of heterozygosity (LOH) status and genomic methylation patterns in order to identify novel changes associated with pediatric AML.

III. To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.

IV. To identify genomic alterations contributing to induction failure in childhood AML.

OUTLINE:

Banked bone marrow samples from diagnosis and remission are used to develop a detailed molecular map of pediatric high-risk acute myeloid leukemia. Analysis includes genome single nucleotide polymorphism (SNP) genotyping, expression, and methylation profiling.


Sponsor: Children's Oncology Group

Current Primary Outcome:

  • Detailed molecular map of pediatric high-risk acute myeloid leukemia [ Time Frame: Baseline ]
  • Mutations in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ]
  • Expression profile in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ]
  • Gene copy number in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ]
  • LOH status in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ]
  • Genomic methylation patterns in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ]
  • Genomic and transcriptome alterations associated with induction failure [ Time Frame: Baseline ]
  • Genomic alterations contributing to induction failure in childhood AML [ Time Frame: Baseline ]


Original Primary Outcome: Detailed molecular map of pediatric high-risk acute myeloid leukemia

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Children's Oncology Group

Dates:
Date Received: February 25, 2010
Date Started: March 2010
Date Completion:
Last Updated: May 17, 2016
Last Verified: May 2016