Studying Genes in Samples From Younger Patients With Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT01653613
- Lead Sponsor
- Eastern Cooperative Oncology Group
- Brief Summary
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).
- Detailed Description
OBJECTIVES:
* 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).
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method