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Test ID COGBF 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, but appropriate testing and interpretation may be compromised or delayed. If this information is 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.

 

Acceptable:

Specimen Type: Blood

Container/Tube:

Preferred: Yellow top (ACD)

Acceptable: Green top (heparin) or lavender top (EDTA)

Specimen Volume: 6 mL

Collection Instructions: Invert several times to mix blood.


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

5q33 rearrangement, PDGFRB break-apart

9p24.1 rearrangement, JAK2 break-apart

9q34 rearrangement, ABL1 break-apart

7p-, IKZF1/CEP7

 

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 and/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), FISH

Specimen Type

Varies

Specimen Minimum Volume

Blood: 2 mL
Bone Marrow: 1 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Varies Ambient (preferred)
  Refrigerated 

Reference Values

An interpretive report will be provided.

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Performing 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. This test 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 In Process

 

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

NY State Approved

Yes

Forms

If not ordering electronically, complete, print, and send a Children's Oncology Group Test Request (T829) with the specimen.