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

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: February 9, 2012
Last updated: May 17, 2016
Last verified: May 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 Intervention
Genetic: cytogenetic analysis
Genetic: nucleic acid sequencing
Other: diagnostic laboratory biomarker analysis
Other: laboratory biomarker analysis
Other: medical chart review

Study Type: Observational
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

Resource links provided by NLM:

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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
cell samples

Estimated Enrollment: 12
Study Start Date: February 2012
Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   1 Year to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients With Acute Lymphoblastic Leukemia


  • Samples from patients enrolled on COG-AALL0232 with standard-risk (SR) or high-risk (HR) acute lymphoblastic leukemia (ALL) with varying levels of MRD and relapse
  • Diagnostic cells and Day 29 cells from patients that have not relapsed and are 5 years from diagnosis on protocol COG-AALL0232
  • Diagnostic cells and Day 29 cells from patients that are matched for age, sex, initial white blood cell (WBC) count, and cytogenetics that have relapsed


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT01533168

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Norman J. Lacayo, MD Stanford University
  More Information

Responsible Party: Children's Oncology Group Identifier: NCT01533168     History of Changes
Other Study ID Numbers: AALL12B1
AALL12B1 ( Other Identifier: COG )
NCI-2012-00246 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: February 9, 2012
Last Updated: May 17, 2016

Keywords provided by Children's Oncology Group:
childhood acute lymphoblastic leukemia in remission
recurrent childhood acute lymphoblastic leukemia
B-cell childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasm, Residual
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neoplastic Processes
Pathologic Processes
Immunoglobulin Heavy Chains
Immunologic Factors
Physiological Effects of Drugs processed this record on May 25, 2017