Clinical trial NCT01076569: Biomarkers in Bone Marrow Samples From Pediatric Patients With High-Risk Acute Myeloid Leukemia
Official title: Target: Identification for High Risk Childhood AML Based on Genome-Wide Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-02-26
Enrollment: 250
Sex: ALL
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient with a diagnosis of acute myeloid leukemia meeting the other criteria.

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.

Eligibility 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

Primary outcomes:
measure: Detailed molecular map of pediatric high-risk acute myeloid leukemia
timeFrame: Baseline
measure: Mutations in identifying novel changes associated with pediatric AML
timeFrame: Baseline
measure: Expression profile in identifying novel changes associated with pediatric AML
timeFrame: Baseline
measure: Gene copy number in identifying novel changes associated with pediatric AML
timeFrame: Baseline
measure: LOH status in identifying novel changes associated with pediatric AML
timeFrame: Baseline
measure: Genomic methylation patterns in identifying novel changes associated with pediatric AML
timeFrame: Baseline
measure: Genomic and transcriptome alterations associated with induction failure
timeFrame: Baseline
measure: Genomic alterations contributing to induction failure in childhood AML
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Soheil Meshinchi, MD
role: PRINCIPAL_INVESTIGATOR
References: