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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01629745
First received: June 26, 2012
Last updated: July 4, 2012
Last verified: June 2012
  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
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 National Cancer Institute (NCI):

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
Estimated 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

Ages Eligible for Study:   up to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01629745

Sponsors and Collaborators
Children's Oncology Group
Investigators
Principal Investigator: Brent Wood, MD, PhD Seattle Cancer Care Alliance
  More Information

Additional Information:
No publications provided

Responsible Party: Peter C. Adamson, Children's Oncology Group - Group Chair Office
ClinicalTrials.gov Identifier: NCT01629745     History of Changes
Other Study ID Numbers: CDR0000735591, COG-AALL12B6
Study First Received: June 26, 2012
Last Updated: July 4, 2012
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
B-cell childhood acute lymphoblastic leukemia
untreated childhood acute lymphoblastic leukemia

Additional relevant MeSH terms:
Leukemia
Neoplasm, Residual
Neoplasms
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Immunoglobulin Heavy Chains
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014