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Brief Title: Genetic Test To Identify Previously Undetectable Minimal Residual Disease in Cell Samples From Younger Patients With Acute Lymphoblastic Leukemia
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 ID: NCT01533168
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.
Minimum Age: 1 Year
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Name: Norman J. Lacayo, MD
Affiliation: Stanford University
Role: PRINCIPAL_INVESTIGATOR