Studying Biomarkers as a Diagnostic Tool in Samples From Younger Patients With B-Cell Acute Lymphoblastic Leukemia
Status: | Completed |
---|---|
Conditions: | Blood Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | Any |
Updated: | 5/19/2016 |
Start Date: | February 2012 |
OBSERVATIONAL: Replication Profiling as a Diagnostic Tool in B-cell Acute Lymphoblastic Leukemia (ALL)
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
patients with B-cell acute lymphoblastic leukemia. Finding specific biomarkers may help
improve the treatment of patients with B-cell acute lymphoblastic leukemia
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.
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.
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
- Hyperdiploid
- t(12;21) (ETV6/RUNX1)
We found this trial at
1
site
Monrovia, California 91016
Principal Investigator: David Gilbert, MD
Phone: 850-645-7583
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