Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia
Recruitment status was: Not yet recruiting
RATIONALE: Studying samples of blood and bone marrow from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer.
PURPOSE: This laboratory study is looking into genes in samples from younger patients with acute lymphoblastic leukemia (ALL).
Genetic: DNA analysis
Genetic: fluorescence in situ hybridization
Genetic: gene expression analysis
Genetic: microarray analysis
Genetic: mutation analysis
Genetic: polymorphism analysis
Genetic: reverse transcriptase-polymerase chain reaction
Other: laboratory biomarker analysis
|Official Title:||Genomic Analysis of Adolescent and Young Adult Acute Lymphoblastic Leukemia|
- Identification of somatically acquired genetic copy number and sequence alterations [ Designated as safety issue: No ]
- Associations between genetic lesions (including mutations and copy number alterations) and known prognostic factors such as age group and white blood count at the time of diagnosis group using a Fisher exact test or Chi squared [ Designated as safety issue: No ]
- Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion [ Designated as safety issue: No ]
|Study Start Date:||August 2010|
|Estimated Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
- To identify somatically acquired genetic copy number and sequence alterations at the time of diagnosis in adolescent and young adults (AYA) acute lymphoblastic leukemia (ALL) samples and to correlate them with clinical and laboratory characteristics and outcome.
- To identify specific microarray multi-gene and multi-exon expression signatures at the time of diagnosis and to correlate them with clinical and laboratory characteristics and outcome.
- To gain insights into the genetic events that contribute to the formation, development and relapse of AYA ALL by integrating the copy number and sequence alterations with the multi-gene signatures and by comparing these with data already generated in pediatric ALL.
OUTLINE: Cryopreserved samples are analyzed for DNA copy number alterations and loss-of-heterozygosity, gene expression profiling, and mutation analysis by single nucleotide polymorphism (SNP) microarrays, Affymetrix Exon arrays, and whole genome amplification (WGA, Repli-G Qiagen). Confirmation studies are then done by fluorescence in situ hybridization (FISH), reverse transcriptase (RT)-polymerase chain reaction (PCR), and rapid amplification of cDNA ends (RACE).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01653613
|Principal Investigator:||Charles Mullighan, MD||St. Jude Children's Research Hospital|