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Completed

NCT Number: NCT01076569

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

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.

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Key information

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) Hematologic Diseases Hemic and Lymphatic Diseases Leukemia Leukemia, Eosinophilic, Acute Leukemia, Myeloid Leukemia, Myeloid, Acute Neoplasms Neoplasms by Histologic Type Recurrent Childhood Acute Myeloid Leukemia Untreated Childhood Acute Myeloid Leukemia and Other Myeloid Malignancies

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Oncology Group

Monrovia, California, 91006-3776, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

  1. Detailed molecular map of pediatric high-risk acute myeloid leukemia

    Time frame: Baseline

  2. Mutations in identifying novel changes associated with pediatric AML

    Time frame: Baseline

  3. Expression profile in identifying novel changes associated with pediatric AML

    Time frame: Baseline

  4. Gene copy number in identifying novel changes associated with pediatric AML

    Time frame: Baseline

  5. LOH status in identifying novel changes associated with pediatric AML

    Time frame: Baseline

  6. Genomic methylation patterns in identifying novel changes associated with pediatric AML

    Time frame: Baseline

  7. Genomic and transcriptome alterations associated with induction failure

    Time frame: Baseline

  8. Genomic alterations contributing to induction failure in childhood AML

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 26, 2010
Registry last updated
May 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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