Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing
| Registry | NCT01119586 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 350 (Estimated) |
| Sponsor | Children's Oncology Group (Network); collaborators: National Cancer Institute (NCI) |
| Conditions | Leukemia |
| Interventions | DNA analysis, genetic linkage analysis, microarray analysis, nucleic acid sequencing, polymerase chain reaction, polymorphism analysis, laboratory biomarker analysis (Genetic, other) |
| Dates | start 2013-02-01, primary completion 2015-12-01, first posted 2010-05-07, last updated 2016-07-11 |
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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.
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.
Sex: All, ages: 1 Year to 30 Years
DISEASE CHARACTERISTICS: * 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