Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia
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 predict how well patients will respond to treatment.
PURPOSE: This research study is looking at DNA in blood and bone marrow samples from young patients with acute lymphoblastic leukemia.
Genetic: DNA analysis
Other: biologic sample preservation procedure
Other: laboratory biomarker analysis
|Study Design:||Observational Model: Case-Only
Time Perspective: Retrospective
|Official Title:||Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)|
- Determination of genome-wide genotypes [ Designated as safety issue: No ]
- Mechanism for storing, distributing, and tracking usage of blast and germline genomic information [ Designated as safety issue: No ]
- Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes) [ Designated as safety issue: No ]
- Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||November 2009|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
- To manage and oversee determination of genome-wide genotypes using common laboratory methodologies for young patients with newly diagnosed acute lymphoblastic leukemia (ALL).
- To provide a mechanism for storing, distributing, and tracking usage of blast and germline genomic information for approved projects.
- To facilitate research for childhood ALL using genome-wide germline and blast data to identify genetic variations associated with important phenotypes: treatment response (e.g., relapse risk, minimal residual disease status), adverse effects (e.g., osteonecrosis, infection risk, neurotoxicity), risk of ALL, and risk of ALL subtypes (e.g., TEL/AML1, BCR/ABL, T-cell).
- To provide a data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL.
OUTLINE: This is a multicenter study.
DNA from previously collected and banked blood and bone marrow samples is utilized for genome-wide genotyping.
Genotype data is only used to examine specific questions related to the epidemiology and etiology of leukemia, response of leukemia to treatment, risk of recurrence, risk for development of side effects, and complications related to treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01016379
|Study Chair:||Mignon Loh, MD||University of California, San Francisco|