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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01629745
First Posted: June 28, 2012
Last Update Posted: May 19, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Children's Oncology Group
  Purpose

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:

OBJECTIVES:

  • 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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical 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)
Criteria

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
  Contacts and Locations
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)
Investigators
Principal Investigator: Brent Wood, MD, PhD Seattle Cancer Care Alliance
  More Information

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 Submitted: June 26, 2012
First Posted: June 28, 2012
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:
Leukemia
Neoplasm, Residual
Neoplasms by Histologic Type
Neoplasms
Neoplastic Processes
Pathologic Processes
Immunoglobulin Heavy Chains
Immunologic Factors
Physiological Effects of Drugs