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

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT01076569

Collaborator

National Cancer Institute (NCI) (NIH)

250

Enrollment

Location

Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Acute Basophilic Leukemia Childhood Acute Eosinophilic Leukemia Childhood Acute Erythroleukemia (M6) Childhood Acute Megakaryocytic Leukemia (M7) Childhood Acute Minimally Differentiated Myeloid Leukemia (M0) Childhood Acute Monoblastic Leukemia (M5a) Childhood Acute Monocytic Leukemia (M5b) Childhood Acute Myeloblastic Leukemia With Maturation (M2) Childhood Acute Myeloblastic Leukemia Without Maturation (M1) Childhood Acute Myelomonocytic Leukemia (M4) Recurrent Childhood Acute Myeloid Leukemia Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies	Other: laboratory biomarker analysis

Detailed Description

PRIMARY OBJECTIVES:

To provide a detailed, molecular map of pediatric high risk acute myeloid leukemia (AML).
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.
To generate fibroblast cell lines in order to obtain germline nucleic acids from marrow specimens from AML patients with induction failure.
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.

Study Design

Study Type:

Observational

Actual Enrollment :

250 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Ancillary-Correlative (molecular analysis) 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 SNP genotyping, expression, and methylation profiling.	Other: laboratory biomarker analysis Correlative studies

Arm

Intervention/Treatment

Ancillary-Correlative (molecular analysis)

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 SNP genotyping, expression, and methylation profiling.

Other: laboratory biomarker analysis

Correlative studies

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of acute myeloid leukemia
High-risk disease
Treated on COG-AAML03P1 or COG-AAML0531
Meets the following criteria:
Initial remission with no known adverse risk factors
High quantity and quality of ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) available
Highly enriched specimens with >= 50% blast available