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Test Code LAB8647 B-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies

Additional Codes

COGBF


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.


Medical University of South Carolina Note:

On-campus collections: Tube to 99 or deliver to University Extension Hospital Room EH318 
 
Off-campus collections: Do NOT Spin! Specimen to be stored/transported at Ambient temp. 

Secondary ID

113530

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)

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 

Reject Due To

All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.

Reference Values

An interpretive report will be provided.

Interpretation

A neoplastic clone is detected when the percent of cells with an abnormality exceeds the normal reference range for any given probe.

 

The absence of an abnormal clone does not rule out the presence of a neoplastic disorder.

Method Description

This test is performed using commercially available and laboratory-developed probes. Deletion of the CDKN2A locus on chromosome 9, TP53 on chromosome 17, deletion of IKZF1 on chromosome 7, and gain of chromosomes 4, 10, and 17 are detected using enumeration strategy probes. Rearrangements involving ABL2, PDGFRB, MYC, JAK2, ABL1, MLL, ETV6, IGH, MYC, CRLF2 and P2RY8 are detected using a dual-color break-apart (BAP) strategy probe. Dual-color, dual-fusion fluorescence in situ hybridization (D-FISH) strategy probe sets are used to detect t(X/Y;14), t(9;22), t(12;21), t(1;19), and in reflex testing when rearrangements of the MLL gene is detected. If a MYC gene region separation is identified, break-apart BCL2 and BCL6 will be evaluated using a dual-color break-apart (BAP) strategy probe. For enumeration and BAP strategy probe sets, 100 interphase nuclei are scored; 200 interphase nuclei are scored when D-FISH probes are used. Results are expressed as the percent abnormal nuclei.(Unpublished Mayo method)

Day(s) Performed

Monday through Friday

Report Available

7 to 10 days

Specimen Retention Time

4 weeks

Performing Laboratory

Mayo Clinic Laboratories in Rochester

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.