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Laboratory Study of Lymphoblasts in Young Patients With High-Risk Acute Lymphoblastic Leukemia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00896766
First received: May 9, 2009
Last updated: August 10, 2011
Last verified: November 2010
History of Changes
  Purpose

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.


Condition Intervention
Leukemia
 Genetic: loss of heterozygosity analysis
Genetic: microarray analysis
Genetic: polymorphism analysis
Genetic: tumor replication error analysis

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Identification of regions of copy number abnormalities (CNA) and uniparental disomy in leukemic lymphoblasts using Affymetrix GeneChip Mapping 500K array sets [ Designated as safety issue: No ]
  • Identification of regions of CNA and loss-of-heterozygosity using Affymetrix SNP 6.0 microarrays. (Expansion project) [ Designated as safety issue: No ]
  • Gene expression profiles for leukemic lymphoblasts using Affymetrix U133 Plus 2.0 arrays [ Designated as safety issue: No ]
  • Global expression of microRNAs in leukemic lymphoblasts using microRNA gene chips [ Designated as safety issue: No ]
  • Epigenomic profiles using the HpaII tiny fragment Enrichment by Ligation-mediated PCR (HELP) assay. (Expansion project) [ Designated as safety issue: No ]
  • Prioritization of candidate genes and genomic regions for resequencing using array-generated gene expression data and data for CNAs [ Designated as safety issue: No ]
  • Identification of genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896766

Locations
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni     843-792-9321        
Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Stephen P. Hunger, MD Children's Hospital Colorado Center for Cancer and Blood Disorders
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00896766     History of Changes
Other Study ID Numbers: CDR0000496763, COG-AALL06B1
Study First Received: May 9, 2009
Last Updated: August 10, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
childhood acute lymphoblastic leukemia in remission
B-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013