NCT01533168

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 12 (estimated)
• Sponsor: Children's Oncology Group · Network
• Sex: All
• Age: 1 Year – 30 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia

Interventions

Type	Name	Description
GENETIC	cytogenetic analysis
GENETIC	nucleic acid sequencing
OTHER	diagnostic laboratory biomarker analysis
OTHER	laboratory biomarker analysis
OTHER	medical chart review

Timeline

• Start date: 2012-02-01
• Primary completion: 2016-05-01
• First posted: 2012-02-15
• Last updated: 2016-05-18