Genomics Reporting Implementation Guide
3.0.1-SNAPSHOT - Ballot International flag

Genomics Reporting Implementation Guide, published by HL7 International / Clinical Genomics. This guide is not an authorized publication; it is the continuous build for version 3.0.1-SNAPSHOT built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7/genomics-reporting/ and changes regularly. See the Directory of published versions

: ROS1-Fusion-therapuTrial - XML Representation

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<Observation xmlns="http://hl7.org/fhir">
  <id value="ROS1-Fusion-therapuTrial"/>
  <meta>
    <profile
             value="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/therapeutic-implication"/>
  </meta>
  <text>
    <status value="extensions"/>
    <div xmlns="http://www.w3.org/1999/xhtml"><p><b>Generated Narrative: Observation</b><a name="ROS1-Fusion-therapuTrial"> </a><a name="hcROS1-Fusion-therapuTrial"> </a></p><div style="display: inline-block; background-color: #d9e0e7; padding: 6px; margin: 4px; border: 1px solid #8da1b4; border-radius: 5px; line-height: 60%"><p style="margin-bottom: 0px">Resource Observation &quot;ROS1-Fusion-therapuTrial&quot; </p><p style="margin-bottom: 0px">Profile: <a href="StructureDefinition-therapeutic-implication.html">Therapeutic Implication</a></p></div><p><b>status</b>: final</p><p><b>category</b>: Laboratory <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-observation-category.html">Observation Category Codes</a>#laboratory)</span>, Genetics <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="http://terminology.hl7.org/5.3.0/CodeSystem-v2-0074.html">diagnosticServiceSectionId</a>#GE)</span></p><p><b>code</b>: Therapeutic Implication <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-tbd-codes-cs.html">To Be Determined Codes</a>#therapeutic-implication)</span></p><p><b>subject</b>: <a href="Patient-somaticPatient.html">Patient/somaticPatient</a> &quot; HAMSBURG&quot;</p><p><b>effective</b>: 2023-02-01</p><p><b>performer</b>: <a href="Practitioner-pathologistPractitioner.html">Practitioner/pathologistPractitioner</a> &quot; DOLIN&quot;</p><p><b>derivedFrom</b>: <a href="Observation-ROS1-Fusion-var.html">Observation/ROS1-Fusion-var</a></p><blockquote><p><b>component</b></p><p><b>code</b>: Prob assoc phenotype <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#81259-4)</span></p><p><b>value</b>: Non-small cell lung cancer <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://browser.ihtsdotools.org/">SNOMED CT</a>#254637007 &quot;Non-small cell lung cancer (disorder)&quot;)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Medication assessed <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#51963-7)</span></p><p><b>value</b>: Taletrectinib <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote><blockquote><p><b>component</b></p><p><b>code</b>: Associated Therapy <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="CodeSystem-tbd-codes-cs.html">To Be Determined Codes</a>#associated-therapy)</span></p><p><b>value</b>: A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (clinicaltrials.gov#NCT04919811 &quot;NCT04919811&quot;)</span></p></blockquote><blockquote><p><b>component</b></p><p><b>Related Artifact for Observation component</b>: </p><p><b>code</b>: Level of evidence <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> (<a href="https://loinc.org/">LOINC</a>#93044-6)</span></p><p><b>value</b>: Tier I - Level A <span style="background: LightGoldenRodYellow; margin: 4px; border: 1px solid khaki"> ()</span></p></blockquote></div>
  </text>
  <status value="final"/>
  <category>
    <coding>
      <system
              value="http://terminology.hl7.org/CodeSystem/observation-category"/>
      <code value="laboratory"/>
    </coding>
  </category>
  <category>
    <coding>
      <system value="http://terminology.hl7.org/CodeSystem/v2-0074"/>
      <code value="GE"/>
    </coding>
  </category>
  <code>
    <coding>
      <system
              value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
      <code value="therapeutic-implication"/>
    </coding>
  </code>
  <subject>🔗 
    <reference value="Patient/somaticPatient"/>
  </subject>
  <effectiveDateTime value="2023-02-01"/>
  <performer>🔗 
    <reference value="Practitioner/pathologistPractitioner"/>
  </performer>
  <derivedFrom>🔗 
    <reference value="Observation/ROS1-Fusion-var"/>
  </derivedFrom>
  <component>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="81259-4"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://snomed.info/sct"/>
        <code value="254637007"/>
        <display value="Non-small cell lung cancer (disorder)"/>
      </coding>
      <text value="Non-small cell lung cancer"/>
    </valueCodeableConcept>
  </component>
  <component>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="51963-7"/>
        <display value="Medication assessed"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <text value="Taletrectinib"/>
    </valueCodeableConcept>
  </component>
  <component>
    <code>
      <coding>
        <system
                value="http://hl7.org/fhir/uv/genomics-reporting/CodeSystem/tbd-codes-cs"/>
        <code value="associated-therapy"/>
        <display value="Associated Therapy"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <coding>
        <system value="http://clinicaltrials.gov"/>
        <code value="NCT04919811"/>
        <display value="NCT04919811"/>
      </coding>
      <text
            value="A Single-Arm, Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of Taletrectinib in Patients With Advanced or Metastatic ROS1 Positive NSCLC and Other Solid Tumors"/>
    </valueCodeableConcept>
  </component>
  <component>
    <extension
               url="http://hl7.org/fhir/uv/genomics-reporting/StructureDefinition/related-artifact-component">
      <valueRelatedArtifact>
        <type value="citation"/>
        <url
             value="https://www.cancer.net/cancer-types/lung-cancer-non-small-cell/types-treatment"/>
      </valueRelatedArtifact>
    </extension>
    <code>
      <coding>
        <system value="http://loinc.org"/>
        <code value="93044-6"/>
        <display value="Level of evidence"/>
      </coding>
    </code>
    <valueCodeableConcept>
      <text value="Tier I - Level A"/>
    </valueCodeableConcept>
  </component>
</Observation>