Supports the retrieval of the mCODE Patient Bundle containing all relevant mCODE resources (provided by Onconova) for a given patient. It also supports CRUD interactions on all Onconova profiles defined in this Implementation Guide.

A profile representing an adverse event experienced by a cancer patient as a result of an antineoplastic treatment, structured according to the Common Terminology Criteria for Adverse Events (CTCAE). This resource is used to capture and standardize the documentation of adverse events occurring during cancer care, including the type of event, its CTCAE grade, and any mitigation actions taken.

The profile constrains the base FHIR AdverseEvent resource to ensure consistent use of CTCAE codes and grades, and supports linkage to related treatments such as medications, radiotherapy, or surgical procedures documented in Onconova. The profile also provides extensions for recording mitigation strategies, supporting detailed tracking and management of adverse events in cancer patients.

A profile representing aneuploid score for a cancer patient.

This profile extends the GenomicsReporting IG GenomicsBase profile to include specific constraints and extensions relevant to Onconova.

A profile recording of a family member's history of cancer.

This profile is based on the core FHIR FamilyMemberHistory resource rather than the mCODE HistoryOfMetastaticCancer profile to allow for a broader range of cancer history documentation (not limited to metastatic cancer). It includes constraints to ensure that at least one cancer condition is recorded, along with optional extensions for cancer morphology and topography.

A profile representing a cancer patient with specific extensions and constraints for the Onconova use case.

It constrains the mCODE CancerPatient profile to ensure anonymity of the patient information and to introduce additional Onconova-specific case information. Any Patient resource complying with the US Core Patient or mCODE CancerPatient profiles will also comply with this profile.

A profile representing a risk assessment performed for a cancer patient, including the method used, the resulting risk level, and an optional numerical score.

It constraints the mCODE CancerRiskAssessment profile and expands the valuesets for cancer risk assessment methods and values.

A profile representing the cancer stage for a cancer patient.

It constrains the mCODE CancerStage profile to include specific constraints and extensions relevant to Onconova.

A profile representing comorbidities for a cancer patient, i.e. other health conditions that exist alongside the primary cancer diagnosis. Supports existing comorbidity panels such as the Charlson Comorbidity Index (CCI) and Elixhauser Comorbidity Index (ECI) with comorbidity indexes.

The profile constrains the mCODE Comorbidities profile to ensure consistent use of ICD-10 codes for documenting comorbid conditions, and to link the comorbidity information to the Onconova primary cancer condition profile.

A profile representing ECOG performance status score for a cancer patient.

Adds minimal constraints to the mCODE ECOGPerformanceStatus profile to account for Onconova specifics.

A profile representing a genomic variant identified for a cancer patient.

This profile extends the base mCODE GenomicVariant profile (which in turn profiles the Genomics Reporting Variant profile) to include specific constraints and extensions relevant to Onconova.

A profile representing homologous recombination deficiency for a cancer patient.

This profile extends the GenomicsReporting IG GenomicsBase profile to include specific constraints and extensions relevant to Onconova.

A profile representing the imaging-based disease status of a cancer patient.

It constrains the mCODE CancerDiseaseStatus profile to restrict it to imaging-based monitoring evaluated based on RECIST criteria.

A profile representing the Karnofsky performance status score for a cancer patient.

Adds minimal constraints to the mCODE KarnofskyPerformanceStatus profile to account for Onconova specifics.

A profile representing a (reported) observation on certain lifestyle characteristics of a cancer patient (e.g. smoking, drinking, and sleeping habits, environmental exposures, etc.).

It directly profiles the base FHIR Observation resource as this resource is not represented in mCODE, to add relevant observation components for the different lifestyle characteristics.

A profile representing loss of heterozygosity for a cancer patient.

This profile extends the GenomicsReporting IG GenomicsBase profile to include specific constraints and extensions relevant to Onconova.

A profile representing a medication administered to a cancer patient during a systemic therapy (e.g., chemotherapy, immunotherapy), including details about the medication and dosage.

This profile extends the base mCODE CancerRelatedMedicationAdministration profile to introduce additional information about the systemic therapy (e.g. number of cycles, therapeutic role, etc.) and to introduce references to other medication administration given simultaneously to represent combination therapies.

A profile representing microsatellite instability for a cancer patient.

This profile extends the GenomicsReporting IG MicrosatelliteInstability profile to include specific constraints and extensions relevant to Onconova.

A profile representing a specialized molecular tumor board review for a cancer patient. This profile extends the OnconovaTumorBoardReview profile to specify that the review is focused on molecular diagnostics and recommendations.

A profile that records the primary cancer condition, the original or first neoplasm in the body (Definition from: NCI Dictionary of Cancer Terms). Cancers that are not clearly secondary (i.e., of uncertain origin or behavior) should be documented as primary.

It constrains the mCODE PrimaryCancerCondition profile to constrain the terminologies of the cancer topography and morphology extensions to use exclusively ICD-O-3 codes.

This profile can be used to represent the Onconova neoplastic entities of relationship primary, local_recurrence, and regional_recurrence. Local and regional recurrences are indicated using extensions to denote that the condition is a recurrence of a previous condition, and to specify the type of recurrence (local or regional). For example, a local recurrence would be represented as a PrimaryCancerCondition with:

{
    clinicalStatus: {
        coding: [
            {
                system: "http://snomed.info/sct",
                code: "recurrence",
                display: "Recurrence"
            }
        ],
    },
    _clinicalStatus {
        extension: [
            {
                url: "http://onconova.github.io/fhir/StructureDefinition/onconova-ext-recurrence-type",
                valueCodeableConcept: {
                    coding: [
                        {
                            system: "http://snomed.info/sct",
                            code: "255470001",
                            display: "Local (qualifier value)"
                        }
                    ]
                }
            }
        ]
    },
}

A profile representing a summary of a course of radiotherapy delivered to a patient. It records the treatment intent, termination reason, modalities, techniques, number of sessions, and doses delivered to one or more body volumes. Whether the course has been fully delivered or stopped is indicated in the status element.

This profile extends the base mCODE RadiotherapyCourseSummary profile to include specific constraints and requirements for Onconova.

A profile recording the a secondary neoplasm, including location and the date of onset of metastases. A secondary cancer results from the spread (metastasization) of cancer from its original site (Definition from: NCI Dictionary of Cancer Terms).

It constrains the mCODE SecondaryCancerCCondition profile to constrain the terminologies of the cancer topography and morphology extensions to use exclusively ICD-O-3 codes.

A profile representing the serum tumor marker level category for a cancer patient.

This profile extends the base mCODE TNMCategory profile to specify the new TNM category.

A profile representing a surgical procedure performed on a cancer patient, including details about the procedure, its intent, and relevant dates.

It extends the base mCODE CancerRelatedSurgicalProcedure profile to include specific constraints and requirements for Onconova.

A profile representing the TNM distant metastases category for a cancer patient.

This profile extends the base mCODE TNMDistantMetastasesCategory profile to include specific constraints and extensions relevant to Onconova.

A profile representing the TNM grade category for a cancer patient.

This profile extends the base mCODE TNMCategory profile to specify the new TNM category.

A profile representing the TNM lymphatic invasion category for a cancer patient.

This profile extends the base mCODE TNMCategory profile to specify the new TNM category.

A profile representing the TNM perineural invasion category for a cancer patient.

This profile extends the base mCODE TNMCategory profile to specify the new TNM category.

A profile representing the TNM primary tumor category for a cancer patient.

This profile extends the base mCODE TNMPrimaryTumorCategory profile to include specific constraints and extensions relevant to Onconova.

A profile representing the TNM regional nodes category for a cancer patient.

This profile extends the base mCODE TNMRegionalNodesCategory profile to include specific constraints and extensions relevant to Onconova.

A profile representing the TNM residual tumor category for a cancer patient.

This profile extends the base mCODE TNMCategory profile to specify the new TNM category.

A profile representing the TNM stage group for a cancer patient.

It extends the base mCODE TNMStageGroup profile to expand the TNM subcategories and include specific constraints and extensions relevant to Onconova.

A profile representing a line of therapy in a cancer treatment regimen, including details about the therapy line number, associated treatments, and relevant dates.

Due to its abstract conceptual nature, it is based on a FHIR List to capture the specific resources involved in the therapy line. Therapy lines in Onconova are assigned automatically based on existing Procedure and MedicationAdministration resources and are not created manually.

A profile representing a tumor board review for a cancer patient.

This profile extends the base FHIR Procedure resource since there is no equivalent mCODE profile that covers the use case.

A profile representing a tumor marker observation for a cancer patient, including the type of tumor marker and its value.

This profile extends the base mCODE TumorMarkerTest profile to include specific constraints and requirements for Onconova.

If relied on the same use context as mCODE, namely for substances found in tissue or blood or other body fluids that may be a sign of cancer or certain benign (non-cancer) conditions measured at the levels of the protein and substance post-RNA protein synthesis (not at genomic level).

A profile representing tumor mutational burden for a cancer patient.

This profile extends the GenomicsReporting IG TumorMutationalBurden profile to include specific constraints and extensions relevant to Onconova.

A profile representing tumor neoantigen burden for a cancer patient.

This profile extends the GenomicsReporting IG GenomicsBase profile to include specific constraints and extensions relevant to Onconova.

A profile representing the venous invasion category for a cancer patient.

This profile extends the base mCODE TNMCategory profile to specify the new TNM category.

Indicates the role of this medication administration in the context of the overall treatment plan.

Details about an action taken to mitigate or manage the adverse event.

The approximate age of the patient.

The approximate age of the patient at the time of diagnosis of the disease.

Value not provided to maintain the anonymization of the patient's data and conform to data protection regulations for research data.

The grade of the adverse event as defined by the Common Terminology Criteria for Adverse Events (CTCAE).

The morphology of the cancer, represented by a ICD-O-3 code.

The topography of the cancer, represented by a ICD-O-3 code.

The cause of death for the patient.

Indicates that this medication administration was given in combination with another medication administration.

The individuals or organizations that contributed to the patient's care.

Indicates the total number of cycles for this medication administration.

The percentage of data elements categories that have been completed for a patient.

Indicates the last known record date of a patient.

Name of the commercial or registered gene panel used for genomic testing.

The version of the HGVS nomenclature used for representing the variant.

Indicates whether this medication administration is the primary therapy within a therapy line.

A characterization of the tumor board review focused on cancer of unknown primary (CUP) origin.

A comparison of molecular findings discussed during the molecular tumor board review.

A therapeutic recommendation or follow-up action resulting from a molecular tumor board review.

The duration of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.

Indicates that whether the RECIST was interpreted from a radiology report rather than extracted.

Indicates that the condition is a recurrence of a previous condition, and provides a reference to that previous condition.

Indicates the type of recurrence for the condition (local or regional).

The numerical score of the risk assessment.

The intent of the therapy line, such as curative or palliative.

The number representing the sequence of the therapy line in the overall treatment regimen.

The period during which the therapy line was performed.

The date when disease progression was observed during or after the therapy line.

The progression-free survival duration for the therapy line.

A reference to the therapy line associated with this treatment.

The specialization or focus area of the tumor board conducting the review, such as hematologic malignancies or solid tumors.

The specific analyte or substance being measured as a tumor marker, such as PSA, CA-125, or CEA.

Value is not collected and cannot be provided by Onconova.

Codes representing roles for adjunctive therapy in oncology.

Drugs or medication categories used in the mitigation process of an adverse event.

Classification of actions to mitigate adverse events affecting a patient's health.

Procedures undertaken to mitigate the impact of an adverse event on a patient's health.

Adjustments made to a patient's treatment plan in response to an adverse event.

Categories of actions taken to mitigate or manage adverse events in oncology.

A value set of antineoplastic agents.

Common Terminology Criteria for Adverse Events (CTCAE) is a standard classification and severity grading scale for adverse events in clinical trials and oncology practice.

Codes representing various imaging methods used in cancer diagnosis and monitoring.

A value set containing codes for various cancer risk assessment methods.

The causes of death that are relevant for a cancer patient.

A collection of comorbidity panels relevant to cancer patients.

A value set of expected drug effects.

Agents to which a patient may have been exposed.

This value set includes sample ICD-10 codes.

A value set of ICD-O-3 morphology behavior codes.

A value set of ICD-O-3 topography codes.

Bodysites related to an observation

Substances that people use to alter their mental state, often for pleasure or leisure, with effects ranging from relaxation and euphoria to hallucinations and altered perceptions.

A value set representing the types of cancer recurrence, specifically local and regional recurrences.

A non-exhaustive value set containing codes that result from risk assessments, i.e., the risk level of the cancer.

Smoking status of a patient

TNM Distant Metastasis Categories Value Set

TNM Grade Categories Value Set

TNM Grade Category Methods Value Set

TNM Lymphatic Invasion Categories Value Set

TNM Perineural Invasion Categories Value Set

TNM Primary Tumor Categories Value Set

TNM Regional Nodes Categories Value Set

TNM Residual Tumor Categories Value Set

TNM Serum Tumor Marker Level Categories Value Set

TNM Venous Invasion Categories Value Set

Codes representing reasons for terminating a treatment in oncology.

A value set of recommendations that may be made by a tumor board for a cancer patient.

Codes representing analytes for tumor markers.

A code system for comorbidity panels relevant to cancer patients.

A code system for codes that are yet to be determined.