B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies
Use
This test is utilized for detecting recurrent common chromosome abnormalities associated with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL) and BCR::ABL1-like acute lymphoblastic leukemia/lymphoma in patients being considered for enrollment in Children's Oncology Group (COG) clinical trials and research protocols. It serves as an adjunct to conventional chromosome studies in pediatric patients with B-ALL and Ph-like ALL being considered for enrollment in COG protocols. Additionally, this test is useful for evaluating specimens in which chromosome studies are unsuccessful. However, it should not be used to screen for residual B-ALL/LBL.
Special Instructions
This test is only performed on specimens from pediatric patients being considered for enrollment in a Children's Oncology Group (COG) protocol. Additional charges will be incurred for all reflex or additional probe sets performed. Analysis charges will be based on the number of cells analyzed per probe set. If no cells are available, no charges will be incurred. A Children's Oncology Group registration number and protocol number should be submitted with each specimen. If this information is not provided, appropriate testing may be compromised or delayed. Flow cytometry and a bone marrow pathology report should be submitted with each specimen.
Limitations
This test is not approved by the US Food and Drug Administration and is best used as an adjunct to clinical and pathologic information. Fluorescence in situ hybridization (FISH) is not a substitute for conventional chromosome studies, which can detect chromosome abnormalities associated with other hematologic disorders that would be missed in a targeted B-cell acute lymphoblastic leukemia/lymphoma FISH panel test. Bone marrow is the preferred specimen type for this FISH test. If bone marrow is not available, a blood specimen may be used if there are circulating malignant cells in the blood as verified by a hematopathologist. If no FISH signals are observed post-hybridization, the case will be released as lack of FISH results.
New York Approved
Methodology
Chromosomal / Cytogenetics (FISH)
Biomarkers
LOINC Codes
- 102100-5
- 50397-9
- 69965-2
- 93356-4
- 62356-1
Result Turnaround Time
7-10 days
Related Documents
For more information, please review the documents below
Specimen
Bone Marrow
Volume
2 to 3 mL
Minimum Volume
1 mL
Container
Yellow top (ACD)
Collection Instructions
It is preferable to send the first aspirate from the bone marrow collection. Invert several times to mix bone marrow. Send bone marrow specimen in original tube. Do not aliquot.
Causes for Rejection
Fresh tissue
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | Ambient (preferred) |