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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01076569
First received: February 25, 2010
Last updated: May 17, 2016
Last verified: May 2016
  Purpose
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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis

Resource links provided by NLM:


Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • Detailed molecular map of pediatric high-risk acute myeloid leukemia [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Mutations in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Expression profile in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Gene copy number in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • LOH status in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Genomic methylation patterns in identifying novel changes associated with pediatric AML [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Genomic and transcriptome alterations associated with induction failure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Genomic alterations contributing to induction failure in childhood AML [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
bone marrow

Enrollment: 250
Study Start Date: March 2010
Study Completion Date: May 2016
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patient with a diagnosis of acute myeloid leukemia meeting the other criteria.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01076569

Locations
United States, California
Children's Oncology Group
Monrovia, California, United States, 91006-3776
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Principal Investigator: Soheil Meshinchi, MD Children's Oncology Group
  More Information

Responsible Party: Children's Oncology Group
ClinicalTrials.gov Identifier: NCT01076569     History of Changes
Other Study ID Numbers: AAML10B14  NCI-2011-02212  COG-AAML10B14  AAML10B14  AAML10B14  U10CA098543 
Study First Received: February 25, 2010
Last Updated: May 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia
Leukemia, Monocytic, Acute
Leukemia, Myelomonocytic, Acute
Hypereosinophilic Syndrome
Leukemia, Erythroblastic, Acute
Leukemia, Eosinophilic, Acute
Leukemia, Basophilic, Acute
Leukemia, Megakaryoblastic, Acute
Neoplasms by Histologic Type
Neoplasms
Eosinophilia
Leukocyte Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 27, 2016