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Genetic Test in Detecting Minimal Residual Disease in Samples From Younger Patients Registered on the COG-AALL08B1 Trial

This study has been completed.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group Identifier:
First received: June 26, 2012
Last updated: May 17, 2016
Last verified: May 2016

RATIONALE: Testing for minimal residual disease in blood samples from patients with acute lymphoblastic leukemia may help doctors plan better treatment.

PURPOSE: This research trial studies a genetic test in detecting minimal residual disease in samples from younger patients registered on COG-AALL08B1 trial.

Condition Intervention
Leukemia Genetic: gene expression analysis Other: flow cytometry Other: laboratory biomarker analysis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Feasibility of Minimal Residual Disease (MRD) Determination in Pediatric B-Lineage ALL Using Deep Sequencing of the Immunoglobulin Heavy Chain Locus

Resource links provided by NLM:

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

Primary Outcome Measures:
  • Sensitivity of deep sequencing of the immunoglobulin heavy chain locus in determining MRD in B-lineage ALL

Estimated Enrollment: 99
Study Start Date: June 2012
Study Completion Date: May 2016
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Detailed Description:


  • Assess the feasibility of minimal residual disease (MRD) determination in pediatric B-lineage acute lymphoblastic leukemia (ALL) using deep sequencing of the immunoglobulin heavy chain locus.

OUTLINE: Archived blood and tumor tissue samples are analyzed for MDR using deep sequencing of immunoglobulin heavy chain locus. MDR quantification results are then compared with the flow cytometry reference methods used in COG studies.


Ages Eligible for Study:   up to 30 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples from patients registered on the Children Oncology Group (COG - AALL08B1)


  • Samples from patients registered on the Children Oncology Group (COG)-AALL08B1 protocol and stored in the Hematopathology Laboratory at the University of Washington

    • Pretreatment and after induction therapy samples


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT01629745

Sponsors and Collaborators
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Brent Wood, MD, PhD Seattle Cancer Care Alliance
  More Information

Responsible Party: Children's Oncology Group Identifier: NCT01629745     History of Changes
Other Study ID Numbers: AALL12B6
COG-AALL12B6 ( Other Identifier: Children's Oncology Group )
NCI-2012-01981 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
Study First Received: June 26, 2012
Last Updated: May 17, 2016

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

Additional relevant MeSH terms:
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Immunoglobulin Heavy Chains
Immunologic Factors
Physiological Effects of Drugs processed this record on July 19, 2017