Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia
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|ClinicalTrials.gov Identifier: NCT01533168|
Recruitment Status : Completed
First Posted : February 15, 2012
Last Update Posted : May 18, 2016
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.
|Condition or disease||Intervention/treatment|
|Leukemia||Genetic: cytogenetic analysis Genetic: nucleic acid sequencing Other: diagnostic laboratory biomarker analysis Other: laboratory biomarker analysis Other: medical chart review|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||12 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||May 2016|
- 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
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533168
|Principal Investigator:||Norman J. Lacayo, MD||Stanford University|