Staging of the pancreatic ductal adenocarcinoma.(1)
Droplet Digital Polymerase Chain Reaction (ddPCR)
Cetuximab (Erbitux)
Colorectal cancer
CRC
EGFR
Epidermal growth factor receptor
Erbitux (Cetuximab)
KRAS
KRAS codon 12
KRAS codon 13
KRAS codon 146
KRAS codon 61
KRAS G12C
KRAS WT
Non-small cell lung cancer
NSCLC
Patiumumab (Vectibix)
RAS
Vectibix (Patiumumab)
Varies
Send specimens refrigerated (4 degrees C)
Pathology report (final or preliminary) is required and must accompany specimen for testing to be performed. At minimum, it should contain the following information:
1. Patient name and second identifier
2. Fluid collection date
3. Source of the fluid
Container/Tube: 50-mL Falcon tube
Preferred: Fresh, peritoneal washing; no fixatives added to wash
Specimen Volume: Two 50-mL Falcon tubes
Collection Instructions: Containers must be labeled with two unique patient identifiers.
Molecular Genetics: Inherited Cancer Syndromes Patient Information (T519)
100 mL of peritoneal washing
Fixative added | Reject |
Specimen Type | Temperature | Time | Special Container |
---|---|---|---|
Varies | Refrigerated |
Staging of the pancreatic ductal adenocarcinoma.(1)
Pancreatic ductal adenocarcinoma (PDAC) is an aggressive malignancy with predilection for peritoneal dissemination. Accurate peritoneal staging is important for management of patients with PDAC. The Kirsten RAS (KRAS) oncogene is the most commonly mutated oncogene in pancreatic ductal adenocarcinoma (PDAC). Detection of KRAS mutations within peritoneal fluid has been associated with clinically positive laparoscopic findings (gross metastases and/or positive peritoneal cytology) and elevated peritoneal fluid CA19-9 and/or carcinoembryonic antigen and may portend an increased risk of residual/recurrent pancreatic cancer metastases within the peritoneal cavity.
This test uses DNA extracted from cells shed into the peritoneum to evaluate for the presence of KRAS (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T) mutations. A positive result indicates the presence of an activating KRAS mutation and can be a useful marker to aid in the staging of pancreatic ductal adenocarcinoma.
An interpretive report will be provided.
The interpretation of molecular biomarker analysis includes an overview of the results and the associated diagnostic, prognostic, and therapeutic implications.
Patients with a negative test result may still harbor a KRAS mutation below the level of detection.
The limit of detection of this assay is influenced by the amount of cells and DNA in the peritoneal wash. This is a biological variable that cannot be controlled.
This assay was designed to detect mutations in KRAS codons 12, 13, 61, and 146 (G12A, G12C, G12D, G12R, G12S, G12V, G13D, Q61K, Q61L, Q61R, Q61H, and A146T).
This test has not been clinically validated for use as a tool to monitor response to therapy or for early detection of tumors.
This test cannot differentiate between somatic and germline alterations.
2. Kim NH, Kim HJ: Preoperative risk factors for early recurrence in patients with resectable pancreatic ductal adenocarcinoma after curative intent surgical resection. Hepatobiliary Pancreat Dis Int. 2018 Oct;17(5):450-455 doi: 10.1016/j.hbpd.2018.09.003
3. Avula LR, Hagerty B, Alewine C: Molecular mediators of peritoneal metastasis in pancreatic cancer. Cancer Metastasis Rev. 2020 Dec;39(4):1223-1243. doi: 10.1007/s10555-020-09924-4
Digital droplet polymerase chain reaction is used to test for the presence of KRAS codon 12, 13, 61, and 146 mutations.(Yonkus JA, Alva-Ruiz R, Abdelrahman AM, et al: Molecular peritoneal staging for pancreatic ductal adenocarcinoma using mutant KRAS droplet-digital polymerase chain reaction: Results of a prospective clinical trial. J Am Coll Surg. 2021 Jul;233(1):73-80.e1. doi: 10.1016/j.jamcollsurg.2021.05.009)
Monday through Friday
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.
81275-KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, variants in codons 12 and 13
81276-KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene) (eg, carcinoma) gene analysis, additional variants
81479 (if appropriate for government payers)
Test Id | Test Order Name | Order LOINC Value |
---|---|---|
KRASW | KRAS Mutation Analysis, Peritoneal | 21702-6 |
Result Id | Test Result Name |
Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
|
---|---|---|
616453 | Result Summary | 50397-9 |
616454 | Result | 82939-0 |
616455 | Interpretation | 69047-9 |
616456 | Specimen | 31208-2 |
616457 | Source | 31208-2 |
616459 | Released By | 18771-6 |
616460 | Method | 85069-3 |
616461 | Disclaimer | 62364-5 |
616462 | Additional Information | 48767-8 |
Change Type | Effective Date |
---|---|
Test Changes - Specimen Information | 2022-07-21 |
New Test | 2022-04-28 |