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Studying Biomarkers as a Diagnostic Tool in Samples From Younger Patients With B-Cell Acute Lymphoblastic Leukemia

This study is not yet open for participant recruitment.
Verified February 2012 by National Cancer Institute (NCI)
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01540578
First received: February 22, 2012
Last updated: NA
Last verified: February 2012
History: No changes posted

February 22, 2012
February 22, 2012
February 2012
April 2012   (final data collection date for primary outcome measure)
Replication-timing changes as a biomarker for further risk prediction [ Designated as safety issue: No ]
Same as current
No Changes Posted
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Studying Biomarkers as a Diagnostic Tool in Samples From Younger Patients With B-Cell Acute Lymphoblastic Leukemia
Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)

RATIONALE: Finding specific biomarkers may help improve the treatment of patients with B-cell acute lymphoblastic leukemia.

PURPOSE: This clinical trial is studying biomarkers as a diagnostic tool in samples from younger patients with B-cell acute lymphoblastic leukemia.

OBJECTIVES:

  • To determine whether we can identify individuals within a specific sub-group of pre-B acute lymphoblastic leukemia (ALL) patients that will eventually recur.
  • To identify replication-timing changes as a biomarker for further risk prediction.
  • To identify differences between patients of similar subtype, and choose candidate differences to analyze by methods that are compatible with frozen samples.

OUTLINE: Archived cell samples are analyzed for replication timing by flow cytometry, microarray, and single-cell fluorescence in situ hybridization (FISH) assays. Replication-timing results among cases and controls are also analyzed.
Interventional
Not Provided
Primary Purpose: Diagnostic
Leukemia
  • Genetic: fluorescence in situ hybridization
  • Genetic: microarray analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: flow cytometry
  • Other: laboratory biomarker analysis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
70
Not Provided
April 2012   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Frozen viable cell samples from patients with B-cell acute lymphoblastic (ALL) of any outcome from the Children's Oncology Group (COG) ALL Cell Bank (Part 1)

  • Fresh and frozen cell samples from patients with B-cell ALL with known outcomes from the COG ALL Cell Bank (Part 2) meeting 1 of the following criteria:

    • Samples from patients who experienced an early recurrence within 36 months of diagnosis (cases)
    • Samples from patients who remain in prolonged remission (controls)

  • No samples meeting either of the following criteria:

    • Very-high-risk features

      • Philadelphia chromosome positive
      • Hypodiploid
      • MLL (11q23) rearranged

    • Known favorable risk factors

      • Hyperdiploid
      • t(12;21) (ETV6/RUNX1)

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
Not Provided
No
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NCT01540578
CDR0000726704, COG-AALL12B3
Not Provided
Peter C. Adamson, Children's Oncology Group - Group Chair Office
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David M. Gilbert, MD Florida State University
National Cancer Institute (NCI)
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP