Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia
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.
Genetic: cytogenetic analysis
Genetic: nucleic acid sequencing
Other: diagnostic laboratory biomarker analysis
Other: laboratory biomarker analysis
Other: medical chart review
|Study Design:||Observational Model: Case Control
Time Perspective: Retrospective
|Official Title:||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|
- Identification and characterization of changes in clonal populations of B cells in children with ALL [ Designated as safety issue: No ]
- Reclassification of patients as MRD positive at day 29 [ Designated as safety issue: No ]
- Higher sensitivity detection that allow the stratification of the MRD population into 2 groups with lower and higher likelihood of relapse [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
|Study Start Date:||February 2012|
|Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01533168
|Principal Investigator:||Norman J. Lacayo, MD||Stanford University|