Biomarkers in DNA Samples From Patients With High-Risk Acute Lymphoblastic Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01119586|
Recruitment Status : Completed
First Posted : May 7, 2010
Last Update Posted : July 11, 2016
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.
|Condition or disease||Intervention/treatment|
|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|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||350 participants|
|Official Title:||Identifying Rare Genetic Variants Involved in High Risk Acute Lymphoblastic Leukemia (ALL) Via Pooled DNA Sequencing|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||December 2015|
- 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
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01119586
|Principal Investigator:||Todd E. Druley, MD||St. Louis Children's Hospital|