Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT01016379|
Recruitment Status : Completed
First Posted : November 19, 2009
Last Update Posted : May 17, 2016
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.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: DNA analysis Other: biologic sample preservation procedure Other: laboratory biomarker analysis|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||Genome-Wide Interrogations in Childhood Acute Lymphoblastic Leukemia (ALL)|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Determination of genome-wide genotypes
- Mechanism for storing, distributing, and tracking usage of blast and germline genomic information
- Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes)
- Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL
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): NCT01016379
|Study Chair:||Mignon Loh, MD||University of California, San Francisco|