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HelpTest Code P53CA Hematologic Neoplasms, TP53 Somatic Mutation, DNA Sequencing Exons 4-9, Varies
Testing Algorithm
Flow cytometry will be performed on peripheral blood samples to verify diagnosis of chronic lymphocytic leukemia (CLL) and to selectively enrich for B cells in samples with a clonal population.
For more information see TP53 Sequencing Testing Algorithm.
Specimen Type
VariesOrdering Guidance
For the evaluation of patients suspected of having an inherited or germline TP53 cancer syndrome (eg, Li Fraumeni syndrome), order one of the following tests containing TP53:
-XCP/ Hereditary Expanded Cancer Panel, Varies
-COMCP / Hereditary Common Cancer Panel, Varies
-BRGYP / Hereditary Breast/Gynecologic Cancer Panel, Varies
-CRCGP / Hereditary Gastrointestinal Cancer Panel, Varies
-PANCP / Hereditary Pancreatic Cancer Panel, Varies
-ENDCP / Hereditary Endocrine Cancer Panel, Varies
-THYRP / Hereditary Thyroid Cancer Panel, Varies
-WILMP / Hereditary Wilms Tumor Panel, Varies
-RENCP / Hereditary Renal Cancer Panel, Varies
-PRS8P / Hereditary Prostate Cancer Panel, Varies
Shipping Instructions
Blood and bone marrow specimens must arrive within 10 days of collection.
Necessary Information
The following information is required:
1. Pertinent clinical history
2. Clinical or morphologic suspicion
3. Date of collection
4. Specimen source
Specimen Required
Submit only 1 of the following specimens:
Specimen Type: Blood (preferred)
Container/Tube: Lavender top (EDTA) or yellow top (ACD solution B)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix blood.
2. Send whole blood specimen in original tube. Do not aliquot.
3. Label specimen as blood.
Specimen Stability Information: Ambient/Refrigerate <10 days
Specimen Type: Bone marrow
Container/Tube: Lavender top (EDTA), yellow top (ACD solution B), or green top (heparin)
Specimen Volume: 3 mL
Collection Instructions:
1. Invert several times to mix bone marrow.
2. Send bone marrow specimen in original tube. Do not aliquot.
3. Label specimen as bone marrow.
Specimen Stability Information: Ambient/Refrigerate <10 days
Specimen Type: Tissue
Container/Tube: Plastic container
Specimen Volume: 100 mg
Collection Instructions: Stabilize fresh tissue in tissue culture medium or freeze immediately after collection.
Specimen Stability Information: Refrigerate 24 hours/ Frozen
Specimen Minimum Volume
Blood, bone marrow: 1 mL
Specimen Stability Information
| Specimen Type | Temperature | Time |
|---|---|---|
| Varies | Varies | 10 days |
Reject Due To
| Gross hemolysis | Reject |
| Extracted DNA | Reject |
| Moderately to severely clotted Formalin-fixed paraffin-embedded tissue |
Reject |
Clinical Information
Patients with chronic lymphocytic leukemia (CLL) have variable disease course influenced by a series of tumor biologic factors. The presence of chromosomal 17p- or a TP53 gene variant confers a very poor prognosis to a subset of CLL patients, both at time of initial diagnosis, as well as at disease progression, or in the setting of therapeutic resistance. TP53 gene variant status in CLL has emerged as the single most predictive tumor genetic abnormality associated with adverse outcome and poor response to standard immunochemotherapy; however, patients can be managed with alternative therapeutic options.
Although the prognostic relevance of an acquired TP53 gene variant is best studied for CLL, similar findings are also reported for other hematologic malignancies including low-grade B-cell lymphoma, diffuse large B-cell lymphoma, and some types of myelodysplastic syndromes and acute myeloid leukemia. Therefore, while this test has been developed to be primarily focused on high-risk CLL patients, TP53 gene sequencing analysis can also be performed in additional neoplasms, as clinically indicated.
Reference Values
Genetic variants present or absent as compared to a reference sequence of the normal TP53 gene
Day(s) Performed
Monday through Friday
Report Available
8 to 14 daysPerforming Laboratory
Mayo Clinic Laboratories in Rochester
CPT Code Information
81352-TP53 (tumor protein 53) (eg, tumor samples), full gene sequence or targeted sequence analysis of >5 exons
Reflex Tests
| Test ID | Reporting Name | Available Separately | Always Performed |
|---|---|---|---|
| CSP53 | TP53 Pre-Analysis Cell Sorting, V | No | No |
Method Name
Polymerase Chain Reaction (PCR) and Sanger Sequencing
Forms
2. If not ordering electronically, complete, print, and send a Hematopathology/Cytogenetics Test Request (T726) with the specimen.