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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT01540578
First received: February 22, 2012
Last updated: June 3, 2013
Last verified: June 2013

February 22, 2012
June 3, 2013
February 2012
January 2100   (final data collection date for primary outcome measure)
Replication-timing changes as a biomarker for further risk prediction [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Replication-timing changes as a biomarker for further risk prediction [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01540578 on ClinicalTrials.gov Archive Site
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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.

Observational
Time Perspective: Retrospective
Not Provided
Retention:   Samples With DNA
Description:

Fresh and frozen bone marrow cells

Non-Probability Sample

Patients with B-cell acute lymphoblastic samples banked at the COG Cell Bank

Leukemia
  • Genetic: fluorescence in situ hybridization
    Correlative studies
  • Genetic: microarray analysis
    Correlative studies
  • Other: diagnostic laboratory biomarker analysis
    Correlative studies
  • Other: flow cytometry
    Correlative studies
  • Other: laboratory biomarker analysis
    Correlative studies
Observational
Archived cell samples are analyzed for replication timing by flow cytometry, microarray analysis, and single-cell fluorescence in situ hybridization (FISH) assays. Replication-timing results among cases and controls are also analyzed by diagnostic laboratory biomarker analysis.
Interventions:
  • Genetic: fluorescence in situ hybridization
  • Genetic: microarray analysis
  • Other: diagnostic laboratory biomarker analysis
  • Other: flow cytometry
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
70
Not Provided
January 2100   (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
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No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01540578
AALL12B3, COG-AALL12B3, CDR0000726704
No
Children's Oncology Group
Children's Oncology Group
National Cancer Institute (NCI)
Principal Investigator: David M. Gilbert, MD Florida State University
Children's Oncology Group
June 2013

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