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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01533168
|Principal Investigator:||Norman J. Lacayo, MD||Stanford University|