Studying Genes in Samples From Younger Patients With 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: NCT01653613|
Recruitment Status : Unknown
Verified July 2012 by National Cancer Institute (NCI).
Recruitment status was: Not yet recruiting
First Posted : July 31, 2012
Last Update Posted : July 10, 2013
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).
|Condition or disease||Intervention/treatment|
|Leukemia||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|
- 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).
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Genomic Analysis of Adolescent and Young Adult Acute Lymphoblastic Leukemia|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||February 2013|
- Identification of somatically acquired genetic copy number and sequence alterations
- 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
- Association between genetic lesion and outcome using a Kaplan-Meier curve and perform logrank test for each lesion
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): NCT01653613
|Principal Investigator:||Charles Mullighan, MD||St. Jude Children's Research Hospital|