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2.1. Profiles and Referenced IG Usage

This specification reuses existing FHIR profiles, search parameter patterns, and terminology artifacts to represent the minimum structured data needed for USCDI+ Clinical Trials Matching (CTM). The data mapping table below identifies how each USCDI+ CTM data element is represented using existing FHIR profiles and element paths. Unless explicitly stated otherwise, this IG adopts the referenced profile definitions as-is and does not change their underlying cardinality.

The mapping table below shows how the USCDI+ CTM data elements are drawn from these referenced profiles and associated terminology bindings to support CTM exchange. This guide also contains an example set of FHIR instances covering the data elements in the table below, which implementers can use to test their implementations. See the list of examples.

2.1.1. US Core Usage

This IG leverages the following US Core profiles for foundational CTM-relevant content:

• US Core Laboratory Result Observation Profile
• US Core Observation Pregnancy Status Profile
• US Core Smoking Status Observation Profile
• US Core Procedure Profile
• US Core Medication Profile

2.1.2. mCODE FHIR IG Usage

This IG leverages the following mCODE profiles for cancer-specific CTM content:

• mCODE Cancer Patient Profile
• mCODE Primary Cancer Condition Profile
• mCODE Secondary Cancer Condition Profile
• mCODE ECOG Performance Status Profile
• mCODE Karnofsky Performance Status Profile
• mCODE Lansky Play Performance Status Profile
• mCODE Comorbidities Profile
• mCODE Cancer Stage Profile
• mCODE TNM Primary Tumor Category Profile
• mCODE TNM Regional Nodes Category Profile
• mCODE TNM Distant Metastases Category Profile
• mCODE Cancer-Related Medication Administration Profile
• mCODE Radiotherapy Course Summary Profile

2.1.3. USCDI+ CTM Dataset to FHIR Mapping

The USCDI+ CTM data elements in this specification were determined through the USCDI+ Cancer process and represent the minimum data necessary to support clinical trial matching. This IG makes significant use of existing FHIR profiles, terminology artifacts, and element definitions from referenced implementation guides, including US Core and mCODE, as identified in the data model table. The table documents how USCDI+ CTM data elements map to those existing FHIR artifacts.The purpose of this data model is therefore to identify the minimum CTM-relevant content to be exchanged and the FHIR artifacts from which that content is drawn, rather than to redefine the underlying profiles.

Data Class	USCDI+ CTM Data Element	USCDI+ Associated FHIR Profile	FHIR Element
Comorbid Conditions	Comorbid Conditions	Comorbidities	Observation.extension:comorbidConditionPresent
Health Status Assessments	Clinical Performance Status	ECOG Performance Status Karnofsky Performance Status Lansky Play Performance Status	Observation.interpretation
Health Status Assessments	Clinical Performance Status Assessment Date	ECOG Performance Status Karnofsky Performance Status Lansky Performance Status	Observation.effective[x]
Health Status Assessments	Pregnancy Status	US Core Observation Pregnancy Status	Observation.value[x]:valueCodeableConcept
Health Status Assessments	Smoking Status	US Core Smoking Status Observation	Observation.code Observation.value[x]
Laboratory	Laboratory Results: Date and Timestamps	Us Core Laboratory Result Observation	Observation.effective[x]
Laboratory	Result Reference Range	US Core Laboratory Result Observation	Observation.referenceRange
Laboratory	Result Unit of Measure	US Core Laboratory Result Observation	Observation.valueQuantity.unit Observation.valueQuantity.system Observation.valueQuantity.code
Laboratory	Tests	US Core Laboratory Result Observation	Observation.code
Laboratory	Values/Results	US Core Laboratory Result Observation	Observation.value[x]
Medications	Date Medication Administered	Cancer-Related Medication Administration Profile	MedicationAdministration.effectiveDateTime
Medications	Medications	Cancer-Related Medication Administration US Core Medication	MedicationAdministration.medication[x] Medication.code
Patient Demographics/Information	Current Address	Cancer Patient	Patient.address
Patient Demographics/Information	Date of Birth	Cancer Patient	Patient.birthDate
Patient Demographics/Information	Ethnicity	Cancer Patient	Patient.extension:ethnicity extension:ombCategory
Patient Demographics/Information	Race	Cancer Patient	Patient.extension:race extension:ombCategory
Problems	Date of Diagnosis	Primary Cancer Condition	Condition.extension:assertedDate
Procedures	Perfomance Time	US Core Procedure	Procedure.performed[x]
Procedures	Procedures	US Core Procedure	Procedure.code
Radiation Therapy	Radiation Cumulative Dose	Radiotherapy Course Summary	Procedure.Extension.doseDeliveredToVolume.totalDoseDelivered.value[x]
Radiation Therapy	Radiation Cumulative Dose Unit of Measure	Radiotherapy Course Summary	Procedure.Extension.doseDeliveredToVolume.totalDoseDelivered.value[x] valueQuantity.code
Radiation Therapy	Radiation Therapy Anatomic Site	Radiotherapy Course Summary	Procedure.bodySite
Radiation Therapy	Radiation Therapy End Date	Radiotherapy Course Summary	Procedure.performedPeriod.end
Radiation Therapy	Radiation Therapy Start Date	Radiotherapy Course Summary	Procedure.performedPeriod.start
Stage	General Staging Method	Cancer Stage	Observation.method
Stage	General Staging Type	Cancer Stage	Observation.code
Stage	General Staging Value	Cancer Stage	Observation.value[x]
Stage	TNM - Category	TNM Stage Group TNMDistantMetastasesCategory TNMPrimaryTumorCategory TNMRegionalNodesCategory	Observation.value[x]
Stage	TNM - Method	TNM Stage Group TNMDistantMetastasesCategory TNMPrimaryTumorCategory TNMRegionalNodesCategory	Observation.method
Stage	TNM - Type	TNM Stage Group TNMDistantMetastasesCategory TNMPrimaryTumorCategory TNMRegionalNodesCategory	Observation.code
Tumor	Histologic Behavior Type	Primary Cancer Condition	Condition.extension:histologyMorphologyBehavior
Tumor	Metastasis Anatomic Site	Secondary Cancer Condition	Condition.bodySite
Tumor	Primary Site	Primary Cancer Condition	Condition.bodySite
Tumor	Recurrence Anatomic Site	Primary Cancer Condition	Condition.bodySite when Condition.clinicalStatus = recurrence