OBSERVATIONAL: Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- B-cell Childhood Acute Lymphoblastic Leukemia
- Sponsor
- Children's Oncology Group
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Replication-timing changes as a biomarker for further risk prediction by FISH
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
This clinical trial is studying biomarkers as a diagnostic tool in samples from younger patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help improve the treatment of patients with B-cell acute lymphoblastic leukemia
Detailed Description
STUDY SUBTYPE: Ancillary/Correlative OBSERVATIONAL STUDY MODEL: Case-only TIME PERSPECTIVE: Retrospective BIOSPECIMEN RETENTION: Samples with DNA BIOSPECIMEN DESCRIPTION: Fresh and frozen bone marrow cells STUDY POPULATION DESCRIPTION: Patients with B-cell acute lymphoblastic samples banked at the COG Cell Bank SAMPLING METHOD: Non-probability sample OBJECTIVES: I. To determine whether we can identify individuals within a specific sub-group of pre-B acute lymphoblastic leukemia (ALL) patients that will eventually recur. II. To identify replication-timing changes as a biomarker for further risk prediction. III. 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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)
- •Freshand 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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Replication-timing changes as a biomarker for further risk prediction by FISH
Time Frame: 2 months