minimal Common Oncology Data Elements (mCODE) Implementation Guide, published by HL7 International / Clinical Interoperability Council. This guide is not an authorized publication; it is the continuous build for version 4.0.0-ballot built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/fhir-mCODE-ig/ and changes regularly. See the Directory of published versions
In addition to providing examples of mCODE profiles, this extended example demonstrates how to represent a clinically realistic scenario.
this styling
.
Patient Jenny M.
is a 55 year old non-Hispanic white female with a past medical history
significant for depression
, a 20-pack-year history of smoking
(current smoker), anxiety
, and hypertension
. Her family history was significant for a maternal aunt with ovarian cancer at age 69
, a sister with breast cancer at age 64
, and adeceased paternal uncle due to pancreatic cancer
.
During a routine screening mammography in February 2018, an abnormality was detected as a possible mass and suspected breast cancer. The gynecologist performing the biopsy refers the patient to an oncologist for further workup. An ultrasound-guided biopsy was performed along with prognostic tumor marker tests with ER positive
, PR negative
, and HER2 negative
. The patient is referred to an oncologist who clinically reviews the mammogram and tumor marker results, and clinical staged the cancer diagnosis
as cT3
N0
.
Genetic counseling ordered a 7 gene panel, and the panel results
revealed a pathogenic variant
in PALB2 (c.3549C>A
).1
A partial mastectomy
was performed, revealing a 2.5 cm tumor with no lymph-vascular invasion
and negative margins of excision
. Three sentinel lymph nodes were excised and were negative for metastatic carcinoma
. The tumor specimen
was sent to the pathologist. The pathology report
revealed a 2.5cm malignant tumor
histological grade 2
invasive ductal
adenocarcinoma with prognostic tumor markers ER positive
, PR negative
, and HER2 negative
. The patient is pathologically staged as pT3
pN0
, stage group IIB
.
A 21-gene RT-PCR assay yielded a recurrence score of 47
.
Treatment options were discussed between the patient and the medical oncologist. With an ECOG performance score
of 0, the patient agrees to receive an AC-T chemotherapy regimen. She received four cycles of doxorubicin (60 mg/m² IV)
and cyclophosphamide (600 mg/m² IV
) followed by paclitaxel (175 mg/m² IV) (AC-T)
, administered on a dose-dense schedule. She subsequently received whole breast radiation therapy
with regional nodal irradiation.
One month following the completion of first-line therapy, the patient is evaluated and with her disease status
improving. The patient will undergo surveillance imaging and monitoring.
A timeline of the narrative is illustrated in the following diagram:
For the purposes of this example, we are assuming that a single relevant variant was returned by the clinical genomics laboratory. In practice, genomics testing may return (many) more variants. The standards for representing genomics data are currently under development by the HL7 Clinical Genomics Work Group. The expectation is that mCODE will adopt those standards when they are completed. ↩