Trial Information
Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
Time Perspective: Retrospective
Outcome Measure:
Replication-timing changes as a biomarker for further risk prediction
Outcome Time Frame:
2 months
Safety Issue:
No
Principal Investigator
David M. Gilbert, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Florida State University
Authority:
United States: Federal Government
Study ID:
AALL12B3
NCT ID:
NCT01540578
Start Date:
February 2012
Completion Date:
Related Keywords:
- Leukemia
- B-cell childhood acute lymphoblastic leukemia
- childhood acute lymphoblastic leukemia in remission
- recurrent childhood acute lymphoblastic leukemia
- Burkitt Lymphoma
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma