MedPath

Studying DNA in Blood and Bone Marrow Samples From Young Patients With Acute Lymphoblastic Leukemia

Completed
Conditions
Leukemia
Registration Number
NCT01016379
Lead Sponsor
Children's 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 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.

Detailed Description

OBJECTIVES:

* 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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
1000
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Data resource, that can be linked with additional tumor cell information, to better characterize the biology and subtypes of childhood ALL
Mechanism for storing, distributing, and tracking usage of blast and germline genomic information
Determination of genome-wide genotypes
Identification of genetic variations associated with important phenotypes (treatment response, adverse effects, risk of acute lymphoblastic leukemia [ALL], and risk of ALL subtypes)
Secondary Outcome Measures
NameTimeMethod
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