Represents the subject that is affected by one or more Cancer Conditions. It has:

• Demographics: demographic information (e.g., sex, birth date or year).
• Life Status (and Cause): evolving status verified during a Visit, after the first treatment, indicating if the patient is alive (with disease or not) or dead (with cause). It can be:
  • Alive, No Evidence of Disease (NED)
  • Dead of Disease (DOD)
  • Dead of Other Cause (DOC)
  • Dead of Unknown Cause (DUC)
  • Alive With Disease (AWD)
• Last Check: date of the Visit in which the Life Status (and Cause) was detected.
• Comorbidities: other relevant diseases that affect the patient.

Life Status (and Cause), Demographics, and Comorbidity can evolve during the journey.

Subject

Directly connected to:

• One or more Cancer Conditions
• One or more Treatments

Indirectly connected with other concepts through Cancer Condition.

If available in EHR, connected to all possible Procedures and Reports as Subject (not reported in Figure 3).

Basing on the availability in EHR, can be directly or indirectly connected with:

• One or more Visits (when the Disease Status could be updated)

Represents the cancer condition at the First Diagnosis, which is the start of the cancer journey. It must have:

• Histology Behaviour: cell type of the neoplasm and whether it is malignant, benign, in situ, or uncertain (typically defined with Surgery and Biopsy).
• Body Site: first location where the Cancer Condition was detected (typically with Imaging).
• Tumour Grade: describes how abnormal the tumour cells/tissues look, indicating biological aggressiveness.
• 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, Genomics).
• Base of Assertion: type of procedure on which the Cancer Condition was detected (e.g., Visit, Biopsy, Surgery, Imaging, Biomarker, Lab Report).

It can have:

• Imaging Type: type of image on which the Cancer Condition was detected.
• Biomarker Type: type of biomarker on which the Cancer Condition was detected.

Each time a patient has a new cancer (not related to the first one), create a new Cancer Condition. If, over time, there is an update related to the same cell type, it is reflected in a new Disease over time and space instance.

If a cancer is metastatic at the First Diagnosis, the information on the metastasis is collected within the Cancer Stage, not in the Disease over time and space instance.

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
• One or more Disease over time and space instances

Basing on the availability in EHR, it can be directly or indirectly connected with:

• One or more Procedures (on which the diagnosis is based)
• A Biopsy (on which the Grading and the Histology Behaviour is defined)
• An Imaging (on which the Body Site is defined)
• One or more Visits (when the Disease Status could be updated)

Represents the stage of the Cancer Condition at the First Diagnosis and describes the tumour extent at the time of the first definitive treatment. It never evolves during the cancer journey. The stage can be Clinical (based on Imaging) or Pathological (based on Surgery).

If, over time, there is an extension of the Cancer Condition (related to the same cell type), it is reflected in a new Disease over time and space instance with Disease Status (e.g., Progression or Recurrence), while the Cancer Stage does not change.

If a cancer is metastatic at the diagnosis, the information on the metastasis is collected within the Cancer Stage, not in the Disease Evolution (over time and space).

Connected with Cancer Condition.

Basing on the availability in EHR, it can be connected with:

• A Surgery (on which the Pathological Stage is defined)
• A Procedure (on which the Clinical Stage is defined)

Represents the evolution over time and over space of the Cancer Condition. Every time there is a new evaluation, there will be a new instance that must have:

• Disease Status: evaluated during a Visit and could be:
  • Progression
  • Stable Disease
  • Partial Remission
  • Complete Remission
  • Recurrence
• Asserted Date: date when evolution is recorded; must correspond to a documented report (e.g., Visit, Imaging, Biomarker, Lab Report).
• Base of Assertion: type of procedure on which the evaluation is based (e.g., Visit, Biopsy, Surgery, Imaging, Biomarker, Lab Report).

It can have:

• Disease Extent: location where the cancer is extended at the time of assertion (typically evaluated with Imaging), with one or more Extent types:
  • Local
  • Loco-regional
  • Metastatic
  and can include one or more Loco-regional sites and Metastatic sites.
• Tumour Grade: new tumor grade, if changed from the first diagnosis (usually does not change).
• Imaging Type: type of image on which the assertion is based.
• Biomarker Type: type of biomarker on which the assertion is based.
• Genomics: genomic description of the extent at the time of assertion.

After the First Diagnosis, every evaluation during a Visit creates a new Disease Evolution instance.

If a cancer is metastatic at the First Diagnosis, the information on the metastasis is collected within the Cancer Stage, not in the Disease Evolution over time and space.

Connected with:

• A Cancer Condition
• One or more Treatments

Basing on the availability in EHR, it can be directly or indirectly connected with:

• One or more Procedures (on which the diagnosis is based)
• A Biopsy (on which the Grading and the Histology Behaviour is defined)
• An Imaging (on which the Disease Extent sites are defined)
• One or more Visits (when the disease evolution is evaluated)

Represents the single or combination of procedures and therapy defined to treat a Cancer Condition or a Disease Extent.

Intent: indicates if it is curative or symptom-relieving; choose from Definitive or Palliative.

It can be divided in 4 main types:

• Surgery: characterized by a Date and a Target Site.
• Active Surveillance: characterized by Start Date and End Date.
• Radiotherapy: characterized by Start Date, End Date, and Target Site.
• Drug Administration: characterized by Start Date, End Date, and a possible indication if the therapy is Ongoing (in case of Immunotherapy).

Typically it is difficult to define if the target is the Cancer Condition or a specific Disease Extent.

Diet or Exercise can be prescribed Treatments but are not considered for the first period.

Treatment: Anti-cancer treatment
Definitive: curative

Connected to:

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

Basing on the availability in EHR, it can be connected with:

• A Report (if the Treatment is a Surgery)
• A Treatment Plan/Prescription (in case of Radiotherapy or Drug Administration)

Represents the standard way to measure how well a cancer patient responds to a single Treatment. It is evaluated by a clinician during a Visit based on an Evidence (e.g., Imaging, Lab Report, Biomarker).

Values include:

• Progression
• Stable Disease
• Partial Remission
• Complete Remission

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 the Treatment while Disease Status represents the evolution of the Cancer Condition over time.

It is the Disease Status that evolves over time, not the Treatment Response.

Connected to a specific Treatment.

Basing on the availability in EHR, it can be connected with:

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

It could be useful to record not only the actual treatment, but also what was planned. Treatment can change based on the Treatment Response. Could also capture guidelines and whether the patient agreed.

It could be useful to consider that a patient can participate in trials and represent its purposes and objectives.

It could be useful to consider questionnaires to evaluate the quality of life and outcomes, but not with priority. They could be recorded during a Visit.

It could be useful, but is difficult to have and can be biased; it often requires hospitalization.

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