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Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)


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Leukemia

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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

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