Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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RATIONALE: Testing for minimal residual disease in cell samples from patients with acute lymphoblastic leukemia may help doctors plan better treatment. PURPOSE: This research trial studies a genetic test in identifying previously undetectable minimal residual disease in cell samples from younger patients with acute lymphoblastic leukemia.

Detailed Description
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OBJECTIVES: To identify and characterize changes in clonal populations of B cells in children with acute lymphoblastic leukemia (ALL) at diagnosis and Day 29 of induction. To define the ability of this technology to reclassify patients as minimal residual disease (MRD) positive at Day 29 of induction. To determine whether more sensitive detection of MRD at Day 29 would have clinical prognostic value in children with ALL. OUTLINE: DNA extracted from diagnostic cells are analyzed for immunoglobulin heavy chain variable region by next-generation sequencing.

Official Title
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Next-Generation Sequencing of Immunoglobulin Heavy Chain Variable Region to Identify Previously Undetectable Minimal Residual Disease in Children With Acute Lymphoblastic Leukemia With Prognostic Significance

Conditions
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Leukemia

Intervention / Treatment
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* Genetic: cytogenetic analysis
* Genetic: nucleic acid sequencing
* Other: diagnostic laboratory biomarker analysis
* Other: laboratory biomarker analysis
* Other: medical chart review


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Samples from patients enrolled on COG-AALL0232 with standard-risk (SR) or high-risk (HR) acute lymphoblastic leukemia (ALL) with varying levels of MRD and relapse Diagnostic cells and Day 29 cells from patients that have not relapsed and are 5 years from diagnosis on protocol COG-AALL0232 Diagnostic cells and Day 29 cells from patients that are matched for age, sex, initial white blood cell (WBC) count, and cytogenetics that have relapsed PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: cytogenetic analysis|nan|
|Genetic: nucleic acid sequencing|nan|
|Other: diagnostic laboratory biomarker analysis|nan|
|Other: laboratory biomarker analysis|nan|
|Other: medical chart review|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification and characterization of changes in clonal populations of B cells in children with ALL |  |  | 
| Reclassification of patients as MRD positive at day 29 |  |  | 
| Higher sensitivity detection that allow the stratification of the MRD population into 2 groups with lower and higher likelihood of relapse |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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childhood acute lymphoblastic leukemia in remission, recurrent childhood acute lymphoblastic leukemia, B-cell childhood acute lymphoblastic leukemia