An actor representing a data consumer that interacts with the Onconova FHIR REST server to retrieve and read patient case data.

An actor representing a data creator that interacts with the Onconova FHIR REST server to create and update patient case data.

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.

Conformance:

AdverseEvent resources representing an adverse event caused by a cancer therapy in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing an aneuploid score obtained through genomic testing in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

A profile recording of a patient's 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.

Conformance:

FamilyMemberHistory resources representing a history of (primary or metastatic) cancer in a patient's family member in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

A profile representing a patient with or is receiving medical treatment for a malignant growth or tumor.

It constrains the mCODE CancerPatient profile with specific extensions and constraints for the Onconova use case. Any Patient resource complying with the US Core Patient or mCODE CancerPatient profiles will also comply with this profile if the Must-Support extensions are accounted for.

Conformance:

Patient resources representing Cancer Patients in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a cancer-related risk assessment in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a cancer staging in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a generic or panel comorbidities assessment in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

A profile representing the (Eastern Cooperative Oncology Group) ECOG performance status score for a cancer patient.

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

Conformance:

Observation resources representing an ECOG performance status score in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a genomic variant in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a homologous recombination deficiency obtained through genomic testing in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a disease status obtained through imaging techniques in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a Karnofsky performance status score in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a summary of a patient's lifestyle in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a loss of heterozygosity obtained through genomic testing in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

Staging of lymphoma (both Hodgkins and Non-Hodgkins) by Ann Arbor, Cotswold, or Lugano staging systems. The method (required) indicates which of these related staging systems was used.

Conformance:

Observation resources representing a lymphoma staging in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Since Onocnova treats systemic therapies involving multiple antineoplastic agents administered together or in sequence as part of a single treatment plan, this profile allows for capturing such relationships between medication administrations using the MedicationAdministration.extension[combinedWith] extension slices.

Conformance:

MedicationAdministration resources representing a systemic therapy in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a microsatellite instability obtained through genomic testing in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Procedure resources representing a molecular tumor board review in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Local and regional recurrences are indicated using the clinicalStatus and clinicalStatus.extension to denote that the condition is a recurrence of a previous condition, and to specify the type of recurrence (local or regional).

Conformance:

Condition resources representing a primary or recurrent neoplastic entity in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Procedure resources representing a radiotherapy in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Condition resources representing a metastatic neoplastic entity in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Procedure resources representing a surgery in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging distant metastases parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging grade category parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging lymphatic invasion parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging perineural invasion parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging primary tumor parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging regional nodes parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging residual tumor parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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

This profile extends the base mCODE TNMCategory profile to specify the new TNM category. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging serum tumor marker level parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a cancer TNM staging in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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

This profile extends the base mCODE TNMCategory profile to specify the new TNM category. Onconova does not provide this resource as an independent resource and is expected to be provided as a contained resource in the TNMStageGroup profile under Obseration.contained.

Conformance:

Observation resources representing a TNM staging venous invasion parameter in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

A profile representing a line of therapy in a cancer treatment regimen, including details about the therapy line number, associated treatments, and relevant dates. It is based on a FHIR EpisodeOfCare 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 usually created manually.

Conformance:

EpisodeOfCare resources representing a therapy line in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Procedure resources representing a tumor board review in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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).

Conformance:

Observation resources representing a tumor marker in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a tumor mutational burden obtained through genomic testing in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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.

Conformance:

Observation resources representing a tumor neoantigen burden obtained through genomic testing in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

A profile representing a collection of vital signs measurements.

Since Onconova does not represent individual vital signs as separate observations, this profile aggregates multiple vital signs into a single Observation resource that can be uniquely identified. It extends the Hl7 FHIR VitalsPanel profile to include specific constraints and requirements for Onconova.

Conformance:

Observation resources representing a collection of vital signs in the scope of Onconova SHALL conform to this profile. Any resource intended to conform to this profile SHOULD populate meta.profile accordingly.

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

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

The date when the adverse event was resolved (if applicable).

The approximate age of the patient.

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

The cause of death for the patient.

The center or hospital where the patient case original records were recorded.

The status of whether the patient has given or revoked consent for research use.

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

The individuals or organizations that contributed to the patient's case data collection.

Indicates the last known record date of a patient.

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.

The status of whether the patient is alive or deceased or unknown.

The actual measured Breslow depth as a quantity

The morphology of a historical cancer associated to a family member of a patient, represented by an ICD-O-3 code.

The topography of a historical cancer associated to a family member of a patient, represented by an ICD-O-3 code.

Whether the condition contributed to the patient's family member's death

Date at which the genomic variant was assessed and/or reported.

The histological differentiation of the tumor.

The categorical classification of the HRD status interpreted from its value.

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

Indicates which medication administrations were given in combination with the current medication administration.

Indicates the total number of cycles for this medication administration.

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.

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 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.

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

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.

The categorical classification of the TMB status interpreted from its value.

Codes representing roles for adjunctive therapy in oncology.

Categories of actions taken to mitigate or manage adverse events 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.

Amino acid change types due to a genomic variant. It constraints and expands the original LOINC Answer List LL380-7 to enforce Onconova-compatible codes

Drugs and biological agents used in the treatment of neoplastic diseases.

Adverse events classified according to the Common Terminology Criteria for Adverse Events (CTCAE)

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.

Categorizations of the clinical relevance of a genomic variant

Coding DNA change types due to a genomic variant. It constraints and expands the original LOINC Answer List LL380-7 to enforce Onconova-compatible codes

A collection of comorbidity panels relevant to cancer patients.

The consent status of a patient for further use of data in research.

Collection of expected effects when a drug is administered.

Agents to which a patient may have been exposed.

The categorical classifications of the HRD status interpreted from its value..

All possible ICD-10 codes for conditions.

The subset of ICD-O-3 concepts dedicated for describing morphology differentiations.

The subset of ICD-O-3 concepts dedicated for describing morphology behavior.

The subset of ICD-O-3 concepts dedicated for describing morphology topographies.

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

Set of surgical procedures relevant to cancer treatment in Onconova.

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

A set of intents for giving a treatment to a cancer patient

Reasons for terminating a treatment in oncology.

Recommendations that may be made by a tumor board for a cancer patient.

Analytes considered tumor markers.

ValueSet containing LOINC and NCI Thesaurus codes for tumor marker laboratory tests and measurements

The categorical classifications of the TMB status interpreted from its value..

The vital status of a patient

A code system for comorbidity panels relevant to cancer patients.

A code system for consent status relevant to Onconova patients.

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