Primary persona: Health System Breast Cancer Clinic

Premise

The Breast Cancer Clinic is interested in sharing physiologic and tumor marker breast cancer data with InsertRegistryName for their patient population of about 5,000 patients. The clinic is interested in piloting an approach to looking at stepwise laboratory testing for their breast cancer cohort. They are using the InsertEHRName EHR system to manage their patients and to provide patient access to their records. Other clinics at this university have worked with InsertRegistryName in the past but they have limited their scope of data sharing to physiologic data, adding tumor marker data would be an expansion of scope for both parties.

Environment in which the persona operates

System architecture of solution

Tumor Markers (existing practice)

Goal: Leverage FHIR-based exchange of breast cancer laboratory data (diagnostic and marker) for treatment refinement

The clinic would like to conduct a retrospective review of laboratory testing data to determine if there is a link between selected therapy options and initial testing steps for breast cancer diagnoses. They agree to focus on HER2 testing, then to refine these results, estrogen and progesterone receptors (IHC) testing and other subsequent testing data both more specific (CEA and cancer antigens 15-3 and 27-29) and more general (CBC and metabolic panel). The initial goal is to determine if there is a viable base pattern to the laboratory test sequencing that leads to selection of therapeutic options.

Current tumor marker context

  • Target population: Uncomplicated (HER2 positive with single tumor) breast cancer patients diagnosed within the last 2 years
  • Desired data elements:
  • Demographic: age, race, gender
  • Physiologic: CBC and metabolic panel, SARS-CoV-2
  • Tissue biomarkers: PD-L1, HER2, Estrogen receptor, and Progesterone receptor
  • Serum tumor markers: CEA, CA 15-3 and CA 27-29
  • Treatment/Medication: cytotoxic chemotherapy, radiation, surgery, hormonal therapy, HER2 therapies, PARP inhibitors, and/or immunotherapy
  • Data elements available: Roughly ~50% structured data for ER, PR and HER2/neu status
  • Data consistency: Some variability across source EMRs (e.g. HER2/neu as positive, negative vs 2+, 3+); some methods unspecified (IHC, FISH)
  • Data format: Most laboratory data codified to LOINC; HGN; other terminologies used for variants (e.g., HGVS expressions)
  • Current transmission capabilities: Custom feeds

Future tumor marker context

  • Target population: All breast cancer patients diagnosed within the last 2 years
  • Desired structured data elements (with standardized units of measure):
  • Demographic: age, race, gender,
  • Stage
  • Family history
  • Histology, grade and behavior
  • Physiologic: CBC and metabolic panel, SARS-CoV-2
  • Tissue biomarkers: PD-L1, HER2, Estrogen receptor, and Progesterone receptor
  • Serum tumor markers: CEA, CA 15-3 and CA 27-29
  • Treatment/Medication: cytotoxic chemotherapy, radiation, surgery, hormonal therapy, HER2 therapies, PARP inhibitors, and/or immunotherapy
  • Data elements available: 100% structured data for ER, PR and HER2/neu status
  • Data consistency: Little to no variability across source EMRs (e.g., HER2/neu as positive, negative vs 2+, 3+); few methods unspecified (IHC, FISH)
  • Data format: All laboratory data codified to LOINC; HGNC; other terminologies used for variants (e.g., HGVS expressions)
  • Transmission capabilities: bulk FHIR