HL7 Europe Common Cancer Model
0.1.0 - ci-build 150

HL7 Europe Common Cancer Model, published by HL7 Europe. This guide is not an authorized publication; it is the continuous build for version 0.1.0 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/hl7-eu/cancer-common/ and changes regularly. See the Directory of published versions

Glossary

Contents:

Concept Overview

Table 1 provides, for each Concept: a description of what it represents, notes (e.g., exclusions or caveats), alternative terms commonly used to indicate it, and its relationships with other Concepts.

On dates and temporality. To rebuild a patient’s cancer journey, dates are fundamental. It is therefore important to identify which concepts (or their attributes) can evolve over time, so you can determine when to update the same instance versus when to create a new one.

Table 1. Concepts in the first version of the European Cancer Common Conceptual Model
Table 1: Concepts, descriptions, notes, synonyms, and connections/dependencies.
Concept Description Note Also known as Connection / Dependency
Patient

Represents the subject affected by one or more Cancer Conditions. Includes:

  • Demographics: demographic information (e.g., sex, birth date or year).
  • Comorbidities: other relevant diseases that affect the patient.

Demographics and Comorbidities can evolve during the journey.

Subject

Directly connected to:

  • One or more Cancer Conditions
  • One or more Treatments

Indirectly connected with other concepts through the Cancer Condition.

If available in EHRs, the patient can be connected as the Subject to Procedures and Reports (not shown in Figure 3).
Cancer Condition

Represents the diagnosed cancer and the start of the cancer journey.

It must have:

  • Histology Behaviour: cell type (histology) and behavior (malignant, benign, in situ, uncertain). Does not change even if Disease Status evolves.
  • Body Site: first location where the Cancer Condition was detected. Does not change even if Disease Status evolves.
  • Tumour Grade: degree of abnormality and biological aggressiveness. Does not change even if Disease Status evolves.
  • Asserted Date: first date when presence of the Cancer Condition was detected; must correspond to a documented report (e.g., Visit, Biopsy, Surgery, Imaging, Biomarker, Lab Report).
  • Base of Diagnosis: type of procedure on which the diagnosis is based (e.g., Visit, Biopsy, Surgery, Imaging, Biomarker, Lab Report).
  • Disease Status (may be absent until the condition evolves): status evaluated during a Visit based on one or more Treatment Responses, such as:
    • Progression
    • Partial Remission
    • Complete Remission
    • Recurrence

It may also specify:

  • Imaging Type: image type on which the condition was detected.
  • Biomarker Type: biomarker type on which the condition was detected.

Each time a patient has a new, unrelated cancer, create a new Cancer Condition. If there is an extension of the original cancer, update the Cancer Stage and reflect it in Disease Status (e.g., as Progression) — the Cancer Condition remains the same.

The pair Histology Behaviour + Body Site identifies the Cancer Condition.

Cancer Condition: Primary Cancer, Secondary Primary Condition
Histology: Morphology
Body Site: Location, Tumor side, Topography

Connected with:

  • A Patient (Subject)
  • A Cancer Stage
  • One or more Treatments

Depending on EHR availability, it can also be connected to:

  • One or more Procedures (supporting diagnosis)
  • A Biopsy (defines Grading and Histology Behaviour)
  • Imaging (supports Body Site)
  • One or more Visits (when Disease Status may be updated)
Cancer Stage
(Clinical Stage and Pathological Stage)

Represents the stage of the Cancer Condition and describes tumour extent at the time of first definitive treatment. The stage can evolve during the journey.

  • Clinical Stage: based on Imaging and clinical evidence.
  • Pathological Stage: based on Surgery and histopathology.

Connected with Cancer Condition.

Depending on EHR availability, it can also be connected to:

  • Surgery (defines Pathological Stage)
  • Procedure (defines Clinical Stage)
Treatment
(Surgery, Active Surveillance, Radiotherapy, Drug Administration)

Represents the single or combined procedures/therapies defined to treat a Cancer Condition.

Intent: indicates whether curative or symptom-relieving; choose from Definitive or Palliative.

Main types:

  • Surgery: characterized by a Date and a Target Side.
  • Active Surveillance: characterized by Start and End dates.
  • Radiotherapy: characterized by Start and End dates and a Target Side.
  • Drug Administration: characterized by Start and End dates and may indicate Ongoing (e.g., immunotherapy).

Diet or Exercise can also be prescribed as Treatments, but are not considered in the first period.

A single Treatment can evolve over time.

Treatment: Anti-cancer treatment
Definitive: Curative

Connected to:

  • One or more Cancer Conditions (Target/Reason)
  • A Patient (Subject)
  • One or more Treatment Responses

Depending on EHR availability, it can also be connected to:

  • A Report (if the Treatment is Surgery)
  • A Treatment Plan / Prescription (for Radiotherapy or Drug Administration)
Treatment Response

Standard way to measure how well a cancer patient responds to a single Treatment, evaluated by a clinician during a Visit and based on Evidence (e.g., imaging, labs, biomarkers).

Values include:

  • Progression
  • Stable Disease
  • Partial Remission
  • Complete Remission
  • Recurrence

Must have:

  • Based on: the type of Evidence used for evaluation (e.g., Imaging, Lab Report, Biomarker).
  • Date: depends on data-source availability (Visit date or Evidence date), and must correspond to a documented report.

Although it may resemble Disease Status, it serves a different purpose: Treatment Response evaluates the effects of a specific Treatment, whereas Disease Status represents the evolution of the Cancer Condition over time.

Connected to a specific Treatment.

Depending on EHR availability, it can also be connected to:

  • One or more Evidence items
  • A Visit (when the response is evaluated)

Table 2. Other concepts discussed but excluded from the first version
Table 2: Additional concepts considered for future focus.
Concept Notes
Treatment Plan

Useful to record planned care in addition to actual treatment; treatment may change based on Treatment Response. Could also capture guideline conformance and whether the patient agreed.

Clinical Trials

Represents participation in clinical trials, including purposes and objectives.
Quality of Life (QoL) / PROMs

Questionnaires to assess quality of life and outcomes; not a priority initially. They could be recorded during a Visit.

Adverse Events / Late Effects / Toxicities

Useful but often difficult to obtain and potentially biased; frequently requires hospitalization to capture reliably.

Risk Factors / Environmental Factors / Genomic Predisposition / Familiarity

Valuable for specific research questions but not prioritized in the first version.