Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia
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.
Genetic: DNA analysis
Genetic: genetic linkage analysis
Genetic: microarray analysis
Genetic: nucleic acid sequencing
Genetic: polymerase chain reaction
Genetic: polymorphism analysis
Other: laboratory biomarker analysis
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing|
- Identification of loci enriched for genetic variation suggestive of pre-B leukemogenesis [ Designated as safety issue: No ]
- 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 [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2013|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01119586
|Principal Investigator:||Todd E. Druley, MD||St. Louis Children's Hospital|