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

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ClinicalTrials.gov Identifier: NCT01629745
Recruitment Status : Completed
First Posted : June 28, 2012
Last Update Posted : May 19, 2016
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group

Brief Summary:

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 or disease Intervention/treatment
Leukemia Genetic: gene expression analysis Other: flow cytometry Other: laboratory biomarker analysis

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.

Study Type : Observational
Estimated Enrollment : 99 participants
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
Study Start Date : June 2012
Primary Completion Date : August 2012
Study Completion Date : May 2016

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

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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): NCT01629745

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

Responsible Party: Children's Oncology Group
ClinicalTrials.gov 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) )
First Posted: June 28, 2012    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 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