Studying Biomarkers as a Diagnostic Tool in Samples From Younger Patients With B-Cell Acute Lymphoblastic Leukemia
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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:
-
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Observational 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. |
Other: laboratory biomarker analysis
Correlative studies
|
Outcome Measures
Primary Outcome Measures
- Replication-timing changes as a biomarker for further risk prediction by FISH [2 months]
Eligibility Criteria
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
-
Hyperdiploid
-
t(12;21) (ETV6/RUNX1)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Children's Oncology Group | Monrovia | California | United States | 91006-3776 |
Sponsors and Collaborators
- Children's Oncology Group
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: David Gilbert, MD, Children's Oncology Group
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AALL12B3
- NCI-2012-00685