DRAFT - CodeX Implementation Guide: Integrated Trial Matching for Cancer Patients and Providers, published by . 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/standardhealth/fsh-pct/ and changes regularly. See the Directory of published versions

Matching Service Integration

Clinical Trial Matching Service Operation Definition

To mCODE™ enable the matching service, FHIR resources are used by the Clinical Trial Matching Service which are defined in this implementation guide.

Clinical Trial Matching Service Input

The inputs include a set parameters and a Trial Match Data Bundle. The Trial Match Data Bundle contains the optimized patient data as mCODE to filter clinical trials. For more information on the mCODE profiles, consult the mCODE specification.

Table 1. Optimized Patient Data Mapped to mCODE

Filter Criteria	Profile	Data Element	Value Set
Age	Cancer Patient	birthDate	N/A, age is dervied from birthdate
Cancer Type	Primary Cancer Condition	code	PrimaryOrUncertainBehaviorCancerDisorderVS
Cancer Sub-type	Primary Cancer Condition	mcode-histology-morphology-behavior	HistologyMorphologyBehaviorVS
Presence of Metastasis	Secondary Cancer Condition	code	SecondaryCancerDisorderVS
Stage	TNM Clinical Stage Group	value	TNMStageGroupVS
	TNM Pathological Stage Group	value	TNMStageGroupVS
Biomarkers	Cancer Genetic Variant	component:GeneStudied	HGNCVS
	Tumor Marker	code	TumorMarkerTestVS
Treatments	Cancer Related Medication Statement	medication	US Core Medication Codes (RxNorm)
	Cancer Related Radiation Procedure	code	RadiationProcedureVS
	Cancer Related Surgical Procedure	code	CancerRelatedSurgicalProcedureVS
Performance Status	ECOG Performance Status	value	N/A, actual result
	Karnofsky Performance Status	value	N/A, actual result

 

Trial Matching Service Output

The matching service returns a Trial Match Result Set. The Trial Match Result Set contains a FHIR ResearchStudy for each matching clinical trial. Each ResearchStudy entry should contain, at a minimum, the following fields

• Title
• Summary
• Site Location
• Phase
• Contact Information (i.e., Sponsor email, phone number)
• Study Type
• Inclusion/Exclusion Criteria

 

Additional Project Links

GitHub Code Repository for the User Interface

GitHub Code Repository for the TrialScope Service Wrapper

GitHub Code Repository for the TrialJectory Service Wrapper

GitHub Code Repository for the BreastCancerTrials.org Service Wrapper

GitHub Code Repository for the Service Library