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NCT Number: NCT00896766

Laboratory Study of Lymphoblasts in Young Patients With High-Risk 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.

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Key information

Conditions

Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Neoplasms Neoplasms by Histologic Type

Age range

1 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hollings Cancer Center at Medical University of South Carolina

Charleston, South Carolina, 29425, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

loss of heterozygosity analysis

Genetic

microarray analysis

Genetic

polymorphism analysis

Genetic

tumor replication error analysis

Genetic

Primary outcomes

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

  2. Identification of regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project)

  3. Gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0 arrays

  4. Global expression of microRNAs in leukemic lymphoblasts using microRNA gene chips

  5. Epigenomic profiles using the HpaII tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay. (Expansion project)

  6. Prioritization of candidate genes and genomic regions for resequencing using array-generated gene expression data and data for CNAs

  7. Identification of genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2016
Study completion
2016
First posted
May 12, 2009
Registry last updated
May 17, 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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