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HelpTest Code LAB000 B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies
Ordering Guidance
This test is only performed on specimens from pediatric patients being considered for enrollment in a Children's Oncology Group (COG) protocol. If this test is ordered and the laboratory is informed that the patient is not on a COG protocol, this test will be canceled and automatically reordered by the laboratory as BALPF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric Varies.
At follow-up, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and targeted B-cell ALL fluorescence in situ hybridization (FISH) probes can be evaluated based on the abnormalities identified in the diagnostic study. Order BALMF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies and request specific probes or abnormalities.
Shipping Instructions
Advise Express Mail or equivalent if not on courier service.
Necessary Information
1. A reason for testing, a flow cytometry and/or a bone marrow pathology report, and a Children's Oncology Group (COG) registration number and protocol number should be submitted with each specimen. The laboratory will not reject testing if this information is not provided; however, appropriate testing and interpretation may be compromised or delayed. If not provided, an appropriate indication for testing may be entered by Mayo Clinic Laboratories.
2. If a patient has received an opposite sex bone marrow transplant prior to specimen collection for this protocol, note this information on the request.
Specimen Required
Submit only 1 of the following specimens:
Preferred:
Specimen Type: Bone marrow
Container/Tube:
Preferred: Yellow top (ACD)
Acceptable: Green top (heparin) or lavender top (EDTA)
Specimen Volume: 2 to 3 mL
Collection Instructions:
1. It is preferable to send the first aspirate from the bone marrow collection.
2. Invert several times to mix bone marrow.
3. Send bone marrow specimen in original tube. Do not aliquot.
Acceptable:
Specimen Type: Blood
Container/Tube:
Preferred: Yellow top (ACD)
Acceptable: Green top (heparin) or lavender top (EDTA)
Specimen Volume: 6 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
Useful For
Evaluation of pediatric bone marrow and peripheral blood specimens by fluorescence in situ hybridization probe analysis for classic rearrangements and chromosomal copy number changes associated with B-cell acute lymphoblastic leukemia/lymphoma (B-ALL) and Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL) in patients being considered for enrollment in Children's Oncology Group (COG) clinical trials and research protocols
As an adjunct to conventional chromosome studies in performed in pediatric patients with B-ALL and Ph-like ALL being considered for enrollment in COG protocols
Testing Algorithm
This test is only performed on specimens from pediatric patients being considered for enrollment in a Children's Oncology Group (COG) protocol.
The FISH panel includes testing for the following abnormalities using the fluorescence in situ hybridization (FISH) probes listed:
+9/9p-, CDKN2A/D9Z1
t(9;22) BCR/ABL1
11q23 rearrangement, MLL (KMT2A) break-apart
-17/17p-, TP53/D17Z1
t(1;19)(q23;p13), PBX1/TCF3
Hyperdiploidy, +4,+10,+17: D4Z1/D10Z1/D17Z1
t(12;21)(p13;q22), ETV6/RUNX1 fusion and iAMP21
14q32 rearrangement, IGH break-apart
t(Xp22.33;var) or t(Yp11.32;var), P2RY8 rearrangement
t(Xp22.33;var) or t(Yp11.32;var), CRLF2 rearrangement
8q24.1 rearrangement, MYC break-apart
If the FISH panel demonstrates normal or nonclassical abnormalities, BALPF / B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric Varies panel will be performed.
The Philadelphia chromosome-like acute lymphoblastic leukemia (Ph-like ALL)panel includes testing for the following kinase activating chromosome abnormalities, using the FISH probes listed below as well as IKZF1 deletion, which often accompanies Ph-like ALL:
1q25 rearrangement, ABL2 break-apart
5q32 rearrangement, PDGFRB break-apart
9p24.1 rearrangement, JAK2 break-apart
9q34 rearrangement, ABL1 break-apart
7p-, IKZF1/CEP7
Appropriate ancillary probes may be performed at consultant discretion to render comprehensive assessment. Any additional probes will have the results included within the final report and will be performed at an additional charge.
When an MLL (KMT2A) rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:
t(4;11)(q21;q23) AFF1/MLL
t(6;11)(q27;q23) MLLT4(AFDN)/MLL
t(9;11)(p22;q23) MLLT3/MLL
t(10;11)(p12;q23) MLLT10/MLL
t(11;19)(q23;p13.1) MLL/ELL
t(11;19)(q23;p13.3) MLL/MLLT1
When an IGH or CRLF2 rearrangement is identified, reflex testing will be performed using the CRLF2/IGH fusion probe set to identify a potential t(X;14)(p22.33;q32) or t(Y;14)(p11.32;q32) cryptic translocation.
In the absence of BCR::ABL1 fusion, when an extra ABL1 signal is identified, reflex testing will be performed using the ABL1 break-apart probe set to evaluate for the presence or absence of an ABL1 rearrangement.
In the absence of ETV6::RUNX1 fusion, when an extra ETV6 signal is identified, reflex testing will be performed using the ETV6 break-apart probe set to evaluate for the presence or absence of an ETV6 rearrangement.
If a MYC rearrangement is identified, both the BCL2 and BCL6 probe sets will be performed.
Method Name
Fluorescence In Situ Hybridization (FISH)
Reporting Name
COG, ALL (B-cell), FISHSpecimen Type
VariesSpecimen Minimum Volume
Blood: 2 mL
Bone Marrow: 1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time | Special Container |
|---|---|---|---|
| Varies | Ambient (preferred) | ||
| Refrigerated | |||
Reject Due To
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.Reference Values
An interpretive report will be provided.
Day(s) Performed
Monday through Friday
Report Available
7 to 10 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
Test Classification
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.CPT Code Information
88271 x 2, 88275, 88291-FISH Probe, Analysis, Interpretation; 1 probe set
88271 x 2, 88275-FISH Probe, Analysis; each additional probe set (if appropriate)
LOINC Code Information
| Test ID | Test Order Name | Order LOINC Value |
|---|---|---|
| COGBF | COG, ALL (B-cell), FISH | 102100-5 |
| Result ID | Test Result Name | Result LOINC Value |
|---|---|---|
| 602296 | Result Summary | 50397-9 |
| 602297 | Interpretation | 69965-2 |
| 602298 | Result Table | 93356-4 |
| 602299 | Result | 62356-1 |
| GC019 | Reason for Referral | 42349-1 |
| GC020 | Specimen | 31208-2 |
| 602301 | Source | 31208-2 |
| 602302 | Method | 85069-3 |
| 602303 | Additional Information | 48767-8 |
| 602304 | Disclaimer | 62364-5 |
| 602305 | Released By | 18771-6 |
Forms
If not ordering electronically, complete, print, and send a Children's Oncology Group Test Request (T829) with the specimen.