Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia
- Conditions
- Leukemia
- Registration Number
- NCT01533168
- Lead Sponsor
- Children's Oncology Group
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method