Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia
NCT ID: NCT01119586
Last Updated: 2016-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
350 participants
OBSERVATIONAL
2013-02-28
Brief Summary
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PURPOSE: This research study is studying biomarkers in DNA samples from patients with newly diagnosed high-risk acute lymphoblastic leukemia.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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DNA analysis
genetic linkage analysis
microarray analysis
nucleic acid sequencing
polymerase chain reaction
polymorphism analysis
laboratory biomarker analysis
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosed with high-risk B-precursor acute lymphoblastic leukemia
* Matched patients non-tumor and blast DNA samples
* Enrolled on COG-P9906 or COG-AALL0232 protocols
* Cohort of random pediatric DNA samples extracted from newborn infants' blood spots from the State of Missouri
PATIENT CHARACTERISTICS:
* Newborn infants from the state of Missouri
PRIOR CONCURRENT THERAPY:
* Not specified
1 Year
30 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Todd E. Druley, MD
Role: PRINCIPAL_INVESTIGATOR
St. Louis Children's Hospital
Other Identifiers
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COG-AALL10B2
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000672526
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02232
Identifier Type: REGISTRY
Identifier Source: secondary_id
AALL10B2
Identifier Type: -
Identifier Source: org_study_id
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