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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01076569
Enrollment
250
Registered
2010-02-26
Start date
2010-03-31
Completion date
2016-05-31
Last updated
2016-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 description

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.

Interventions

OTHERlaboratory biomarker analysis

Correlative studies

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Children's Oncology Group
Lead SponsorNETWORK

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Detailed molecular map of pediatric high-risk acute myeloid leukemiaBaseline
Mutations in identifying novel changes associated with pediatric AMLBaseline
Expression profile in identifying novel changes associated with pediatric AMLBaseline
Gene copy number in identifying novel changes associated with pediatric AMLBaseline
LOH status in identifying novel changes associated with pediatric AMLBaseline
Genomic methylation patterns in identifying novel changes associated with pediatric AMLBaseline
Genomic and transcriptome alterations associated with induction failureBaseline
Genomic alterations contributing to induction failure in childhood AMLBaseline

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026