Leukemia Clinical Trial
Official title:
Childhood Cancer Therapeutically Applicable Research to Generate Effective Treatments (TARGET) Initiative High-Risk ALL Pilot Project: Application of Array-Based Methods and Gene Re-Sequencing to Identify Candidate Molecular Targets for High-Risk Pediatric Acute Lymphoblastic Leukemia
RATIONALE: Collecting and storing samples of bone marrow and blood from patients with cancer
to study in the laboratory may help doctors learn more about changes that may occur in DNA
and identify biomarkers related to cancer.
PURPOSE: This laboratory study is looking at lymphoblasts in young patients with high-risk
acute lymphoblastic leukemia.
OBJECTIVES:
- Identify regions of copy number abnormalities (CNA) and uniparental disomy in leukemic
lymphoblasts from pediatric patients with high-risk acute lymphoblastic leukemia (ALL)
using Affymetrix GeneChip Mapping 500K array sets. (Pilot project)
- Identify regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0
microarrays. (Expansion project)
- Define gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus
2.0 arrays.
- Assess the global expression of microRNAs in leukemic lymphoblasts using microRNA gene
chips.
- Utilize array-generated gene expression data and data for CNAs and uniparental disomy
to prioritize candidate genes and genomic regions for resequencing.
- Characterize epigenomic profiles using the HpaII tiny fragment Enrichment by
Ligation-mediated PCR (HELP) assay. (Expansion project)
- Discover candidate therapeutic targets for these patients by identifying genes that are
consistently mutated in leukemic lymphoblasts using high-throughput focused gene
resequencing. (Pilot project)
- Discover candidate therapeutic targets for these patients by next generation sequencing
technologies, including whole genome, whole transcriptome, and whole exome. (Expansion
project)
OUTLINE: This is a multicenter study.
Banked biological samples (bone marrow and peripheral blood) are analyzed using gene
expression profiling, single-nucleotide polymorphism and genotyping assays, DNA copy number
and loss of heterozygosity estimates, epigenetic profiling, and gene resequencing.
PROJECTED ACCRUAL: A total of 150 patient samples will be accrued for this study.
;
Observational Model: Case-Only, Time Perspective: Retrospective
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