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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


N/A
1 Year
21 Years
Open (Enrolling)
Both
Leukemia

Thank you

Trial Information

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


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of B-cell precursor acute lymphoblastic leukemia (ALL)

- High-risk disease

- Participation in clinical trial COG-P9906 required (pilot project)

- In complete remission

- Consented to future studies using banked tissue specimens

- Participation in clinical trial and COG-AALL03B1 and linked therapeutic studies
COG-AALL0232 and COG- AALL0331(expansion project)

- Experienced a bone marrow relapse within 36 months of initial diagnosis

- Consented to future studies using banked tissue specimens

- Have matched ALL blast and germline specimens

- Demographic, clinical and pathologic data elements for these biospecimens
available

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- Not specified

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Identification of regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts using Affymetrix GeneChip Mapping 500K array sets

Safety Issue:

No

Principal Investigator

Stephen P. Hunger, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Children's Hospital Colorado Center for Cancer and Blood Disorders

Authority:

Unspecified

Study ID:

CDR0000496763

NCT ID:

NCT00896766

Start Date:

July 2006

Completion Date:

Related Keywords:

  • Leukemia
  • childhood acute lymphoblastic leukemia in remission
  • B-cell childhood acute lymphoblastic leukemia
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Name

Location

Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425