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26389 T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies (COGTF)

T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Children's Oncology Group Enrollment Testing, FISH, Varies (COGTF)
Test Code: COGTFSO
Synonyms/Keywords

​9p- (9p deletion) or CDKN2A or p16, t(9;22)(q34;q11.2) - BCR/ABL1, MLL or KMT2A (11q23) rearrangement, t(4;11)(q21;q23) - AFF1/MLL or AFF4/MLL, t(6;11)(q27;q23) - MLLT4(AFDN)/MLL or AFDN/MLL, t(9;11)(p22;q23) - MLLT3/MLL or AF9/MLL, t(10;11)(p13;q23) - MLLT10/MLL, t(11;19)(q23;p13.3) - MLL/MLLT1 or MLL/ENL, t(11;19)(q23;p13.1) - MLL/ELL, 17p- (17p deletion) or TP53, t(5;14)(q35;q32) - TLX3/BCL11B or HOX11L2/BCL11B, T-cell receptor beta (TRB) (7q34) rearrangement, T-cell receptor alpha/delta (TRAD) (14q11.2) rearrangement, t(10;11)(p13;q14) - MLLT10/PICALM or AF10/PICALM, TAL1/STIL (1p33) rearrangement or TAL/SIL, Children's Oncology Group, COG

Test Components

This test is only performed on specimens from pediatric patients being considered for enrollment in a Children's Oncology Group (COG) protocol.

The fluorescence in situ hybridization (FISH) panel includes testing for the following abnormalities using the FISH probes listed:

+9/9p-, CDKN2A/D9Z1

t(9;22) or ABL1 amplification, ABL1/BCR

11q23 rearrangement, MLL (KMT2A) break-apart

-17/17p-, TP53/D17Z1

t(5;14), TLX3/BCL11B fusion

7q34 rearrangement, TRB break-apart

14q11.2 rearrangement, TRAD break-apart

t(10;11), MLLT10/PICALM fusion

1p33 rearrangement, TAL1/STIL

When an MLL (KMT2A) rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(11;19)(q23;p13.3) MLL/MLLT1

t(6;11)(q27;q23) MLLT4(AFDN)/MLL

t(4;11)(q21;q23) AFF1/MLL

t(9;11)(p22;q23) MLLT3/MLL

t(10;11)(p12;q23) MLLT10/MLL

t(11;19)(q23;p13.1) MLL/ELL

When a TRAD rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(11;14)(p15;q11.2) LMO1/TRAD

t(8;14)(q24.1;q11.2) MYC/TRAD

t(10;14)(q24;q11.2) TLX1(HOX11)/TRAD

t(11;14)(p13;q11.2) LMO2/TRAD

When a TRB rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(7;10)(q34;q24) TRB/TLX1

t(7;11)(q34;p15) TRB/LMO1

t(7;11)(q34;p13) TRB/LMO2

t(6;7)(q23;q34) MYB/TRB

In the absence of BCR/ABL1 fusion or apparent episomal ABL1 amplification, 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. 

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 T-cell acute lymphoblastic leukemia in patients being considered for enrollment in Children's Oncology Group clinical trials and research protocols.

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 TALPF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric Varies.

At follow-up, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and targeted T-ALL FISH probes can be evaluated based on the abnormalities identified in the diagnostic study. Order TALMF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies and request specific probes or abnormalities.

If the patient clinically relapses, a conventional chromosome study is useful to identify cytogenetic changes in the neoplastic clone or the possible emergence of a new therapy-related myeloid clone.

For patients with T-cell lymphoma, order TLPDF / T-Cell Lymphoma, Diagnostic FISH, Varies.

For testing paraffin-embedded tissue samples from patients with T-cell lymphoblastic lymphoma, order TLBLF / T-Lymphoblastic Leukemia/Lymphoma, FISH, Tissue.

Specimen Requirements
​Submit only 1 of the following specimens: ​ ​​​​
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)		Pediatric Minimum Volume
(no repeat)
​Bone marrow​Yellow Top (ACD)​Heparin Green Top Tube (GTT) or EDTA Lavender Top Tube (LTT)​3 mL1 mL​
​Whole Blood​Yellow Top (ACD)​Heparin Green Top Tube (GTT) or EDTA Lavender Top Tube (LTT)​6 mL​2 mL​
Collection Processing Instructions

​It is preferable to send the first aspirate from the bone marrow collection.

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 the patient has received an opposite sex bone marrow transplant, note this information on the request. 

Specimen Stability Information
Specimen TypeTemperature
​Varies ​​ Ambient (preferred)
​Refrigerated
Rejection Criteria
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.
Interference

This test is not approved by the US Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.

Fluorescence in situ hybridization (FISH) is not a substitute for conventional chromosome studies because the latter detects many chromosome abnormalities associated with other hematological disorders that would be missed by this 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 malignant cells in the blood specimen (as verified by a hematopathologist).

Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
Mayo Clinic Laboratories​​Monday through Friday​7 to 10 days​Fluorescence In Situ Hybridization (FISH)
Reference Lab
Mayo Clinic Laboratories
Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories​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 neoplastic disorder.

Outreach CPTs
CPTModifier
(if needed)		QuantityDescriptionComments
​88271​​2​​
​88275​​1​​
​88291​​1​​
​88271​​2​FISH Probe, Analysis​if appropriate
​88275​​1 ​Each additional probe set​if appropriate
Synonyms/Keywords

​9p- (9p deletion) or CDKN2A or p16, t(9;22)(q34;q11.2) - BCR/ABL1, MLL or KMT2A (11q23) rearrangement, t(4;11)(q21;q23) - AFF1/MLL or AFF4/MLL, t(6;11)(q27;q23) - MLLT4(AFDN)/MLL or AFDN/MLL, t(9;11)(p22;q23) - MLLT3/MLL or AF9/MLL, t(10;11)(p13;q23) - MLLT10/MLL, t(11;19)(q23;p13.3) - MLL/MLLT1 or MLL/ENL, t(11;19)(q23;p13.1) - MLL/ELL, 17p- (17p deletion) or TP53, t(5;14)(q35;q32) - TLX3/BCL11B or HOX11L2/BCL11B, T-cell receptor beta (TRB) (7q34) rearrangement, T-cell receptor alpha/delta (TRAD) (14q11.2) rearrangement, t(10;11)(p13;q14) - MLLT10/PICALM or AF10/PICALM, TAL1/STIL (1p33) rearrangement or TAL/SIL, Children's Oncology Group, COG

Test Components

This test is only performed on specimens from pediatric patients being considered for enrollment in a Children's Oncology Group (COG) protocol.

The fluorescence in situ hybridization (FISH) panel includes testing for the following abnormalities using the FISH probes listed:

+9/9p-, CDKN2A/D9Z1

t(9;22) or ABL1 amplification, ABL1/BCR

11q23 rearrangement, MLL (KMT2A) break-apart

-17/17p-, TP53/D17Z1

t(5;14), TLX3/BCL11B fusion

7q34 rearrangement, TRB break-apart

14q11.2 rearrangement, TRAD break-apart

t(10;11), MLLT10/PICALM fusion

1p33 rearrangement, TAL1/STIL

When an MLL (KMT2A) rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(11;19)(q23;p13.3) MLL/MLLT1

t(6;11)(q27;q23) MLLT4(AFDN)/MLL

t(4;11)(q21;q23) AFF1/MLL

t(9;11)(p22;q23) MLLT3/MLL

t(10;11)(p12;q23) MLLT10/MLL

t(11;19)(q23;p13.1) MLL/ELL

When a TRAD rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(11;14)(p15;q11.2) LMO1/TRAD

t(8;14)(q24.1;q11.2) MYC/TRAD

t(10;14)(q24;q11.2) TLX1(HOX11)/TRAD

t(11;14)(p13;q11.2) LMO2/TRAD

When a TRB rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(7;10)(q34;q24) TRB/TLX1

t(7;11)(q34;p15) TRB/LMO1

t(7;11)(q34;p13) TRB/LMO2

t(6;7)(q23;q34) MYB/TRB

In the absence of BCR/ABL1 fusion or apparent episomal ABL1 amplification, 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. 

Ordering Applications
Ordering ApplicationDescription
​COM​T-Cell Acute Lymph Leuk (COGTF)
​Cerner​T-Cell Acute Lymphoblastic Leukemia, Children's Oncology Group Enrollment Testing, FISH (COGTF)
If the ordering application you are looking for is not listed, contact your local laboratory for assistance.
Specimen Requirements
​Submit only 1 of the following specimens: ​ ​​​​
Specimen TypePreferred Container/TubeAcceptable Container/TubeSpecimen VolumeSpecimen Minimum Volume
(allows for 1 repeat)		Pediatric Minimum Volume
(no repeat)
​Bone marrow​Yellow Top (ACD)​Heparin Green Top Tube (GTT) or EDTA Lavender Top Tube (LTT)​3 mL1 mL​
​Whole Blood​Yellow Top (ACD)​Heparin Green Top Tube (GTT) or EDTA Lavender Top Tube (LTT)​6 mL​2 mL​
Collection Processing

​It is preferable to send the first aspirate from the bone marrow collection.

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 the patient has received an opposite sex bone marrow transplant, note this information on the request. 

Specimen Stability Information
Specimen TypeTemperature
​Varies ​​ Ambient (preferred)
​Refrigerated
Rejection Criteria
All specimens will be evaluated at Mayo Clinic Laboratories for test suitability.
Interference

This test is not approved by the US Food and Drug Administration, and it is best used as an adjunct to existing clinical and pathologic information.

Fluorescence in situ hybridization (FISH) is not a substitute for conventional chromosome studies because the latter detects many chromosome abnormalities associated with other hematological disorders that would be missed by this 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 malignant cells in the blood specimen (as verified by a hematopathologist).

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 T-cell acute lymphoblastic leukemia in patients being considered for enrollment in Children's Oncology Group clinical trials and research protocols.

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 TALPF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), FISH, Pediatric Varies.

At follow-up, conventional cytogenetic studies (CHRBM / Chromosome Analysis, Hematologic Disorders, Bone Marrow) and targeted T-ALL FISH probes can be evaluated based on the abnormalities identified in the diagnostic study. Order TALMF / T-Cell Acute Lymphoblastic Leukemia/Lymphoma (ALL), Specified FISH, Varies and request specific probes or abnormalities.

If the patient clinically relapses, a conventional chromosome study is useful to identify cytogenetic changes in the neoplastic clone or the possible emergence of a new therapy-related myeloid clone.

For patients with T-cell lymphoma, order TLPDF / T-Cell Lymphoma, Diagnostic FISH, Varies.

For testing paraffin-embedded tissue samples from patients with T-cell lymphoblastic lymphoma, order TLBLF / T-Lymphoblastic Leukemia/Lymphoma, FISH, Tissue.

Test Components

This test is only performed on specimens from pediatric patients being considered for enrollment in a Children's Oncology Group (COG) protocol.

The fluorescence in situ hybridization (FISH) panel includes testing for the following abnormalities using the FISH probes listed:

+9/9p-, CDKN2A/D9Z1

t(9;22) or ABL1 amplification, ABL1/BCR

11q23 rearrangement, MLL (KMT2A) break-apart

-17/17p-, TP53/D17Z1

t(5;14), TLX3/BCL11B fusion

7q34 rearrangement, TRB break-apart

14q11.2 rearrangement, TRAD break-apart

t(10;11), MLLT10/PICALM fusion

1p33 rearrangement, TAL1/STIL

When an MLL (KMT2A) rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(11;19)(q23;p13.3) MLL/MLLT1

t(6;11)(q27;q23) MLLT4(AFDN)/MLL

t(4;11)(q21;q23) AFF1/MLL

t(9;11)(p22;q23) MLLT3/MLL

t(10;11)(p12;q23) MLLT10/MLL

t(11;19)(q23;p13.1) MLL/ELL

When a TRAD rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(11;14)(p15;q11.2) LMO1/TRAD

t(8;14)(q24.1;q11.2) MYC/TRAD

t(10;14)(q24;q11.2) TLX1(HOX11)/TRAD

t(11;14)(p13;q11.2) LMO2/TRAD

When a TRB rearrangement is identified, reflex testing will be performed to identify the translocation partner. Probes include identification of:

t(7;10)(q34;q24) TRB/TLX1

t(7;11)(q34;p15) TRB/LMO1

t(7;11)(q34;p13) TRB/LMO2

t(6;7)(q23;q34) MYB/TRB

In the absence of BCR/ABL1 fusion or apparent episomal ABL1 amplification, 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. 

Reference Range Information
Performing LocationReference Range
​Mayo Clinic Laboratories​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 neoplastic disorder.

For more information visit:
Performing Laboratory Information
Performing LocationDay(s) Test PerformedReport AvailableMethodology/Instrumentation
Mayo Clinic Laboratories​​Monday through Friday​7 to 10 days​Fluorescence In Situ Hybridization (FISH)
Reference Lab
Mayo Clinic Laboratories
For billing questions, see Contacts
Outreach CPTs
CPTModifier
(if needed)		QuantityDescriptionComments
​88271​​2​​
​88275​​1​​
​88291​​1​​
​88271​​2​FISH Probe, Analysis​if appropriate
​88275​​1 ​Each additional probe set​if appropriate
For most current information refer to the Marshfield Laboratory online reference manual.