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Clinical Trials/NCT01119586
NCT01119586
Completed
Not Applicable

Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing

Children's Oncology Group0 sites350 target enrollmentFebruary 2013
ConditionsLeukemia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Leukemia
Sponsor
Children's Oncology Group
Enrollment
350
Primary Endpoint
Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

RATIONALE: Studying samples of blood or tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.

Detailed Description

OBJECTIVES: * To perform pooled DNA sequencing in 56 genes from the genomic DNA of unaffected children and matched non-tumor and blast DNA from patients with high-risk (HR) acute lymphoblastic leukemia (ALL) enrolled on COG HR ALL protocols. * To identify loci enriched for genetic variation between DNA of unaffected children and DNA of these patients. * To individually validate novel, putatively functional single nucleotide polymorphisms (SNPs) identified via pooled sequencing with another genotyping platform. * To correlate HR ALL with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation. OUTLINE: DNA specimens from unaffected children (pool 1) and from patients with non-tumor (pool 2) and leukemia blasts (pool 3) are analyzed for genetic pathophysiology of pre-B acute lymphoblastic leukemia by microarray and PCR assays. Sequencing is performed on each of the 3 PCR pools of DNA.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
December 2015
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis

Correlation between high-risk acute lymphoblastic leukemia with clinical phenotypes, co-morbidities, toxicities, outcomes to the genes or pathways found to harbor a significant increase in genetic variation

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