Uploaded image for project: 'FHIR Specification Feedback'
  1. FHIR Specification Feedback
  2. FHIR-26426

Add new component for 'Potential Clinical Trial Match'

    XMLWordPrintableJSON

Details

    • Icon: Change Request Change Request
    • Resolution: Persuasive with Modification
    • Icon: Medium Medium
    • Genomics Reporting (FHIR)
    • 1.0 [deprecated]
    • Clinical Genomics
    • (NA)
    • Hide
      • Persuasive with mod
      • Include a summary of known supported use cases on the therapeutic implication page. These will include at least: 
      • Somatic PGx
      • Implication of NC_000017.11:g.39723967_39723981del in breast cancer - responsive to lapatinib
      • Implication of NM_007294.4(BRCA1):c.5578del in breast cancer - presumed responsive to olaparib+bevacizumab
      • Somatic clinical trials
      • Implication of NC_000010.11:g.121498525T>G in breast cancer - eligible for clinical trial NCT01234567
      • Germline PGx
      • Implication of CYP2C19 *1/*2 genotype - intermediate metabolizer of clopidogrel
      • Implication of RYR1 mutation - high risk of reaction to halogenated anesthetics
      • Implication of SLCO1B1 *1/*14 genotype - increased transporter function with increased simvastatin exposure
      • Implication of rs17244841 AA genotype - increased efficacy of simvastatin
      • Implication of CYP2C19 *2/*2 AND CYP2D6 *2/*2 - poor metabolizer of amitriptyline
      • Germline clinical trials
      • Implication of APOE e1/e1 genotype - ineligible for clinical trial NCT03131453
      • Include an example of how a clinical trial match can be represented as a therapeutic implication. 
      • Include SNOMED codes 444734003|Does not meet eligibility criteria for clinical trial (finding); 399223003|Patient eligible for clinical trial (finding) into the value set for the new 'predicted-therapeutic-implication' component.

      NOTE: FHIR-34277 will introduce a new extension that would allow referencing a "ResearchStudy" resource.

      Show
      Persuasive with mod Include a summary of known supported use cases on the therapeutic implication page. These will include at least:  Somatic PGx Implication of NC_000017.11:g.39723967_39723981del in breast cancer - responsive to lapatinib Implication of NM_007294.4(BRCA1):c.5578del in breast cancer - presumed responsive to olaparib+bevacizumab Somatic clinical trials Implication of NC_000010.11:g.121498525T>G in breast cancer - eligible for clinical trial NCT01234567 Germline PGx Implication of CYP2C19 *1/*2 genotype - intermediate metabolizer of clopidogrel Implication of RYR1 mutation - high risk of reaction to halogenated anesthetics Implication of SLCO1B1 *1/*14 genotype - increased transporter function with increased simvastatin exposure Implication of rs17244841 AA genotype - increased efficacy of simvastatin Implication of CYP2C19 *2/*2 AND CYP2D6 *2/*2 - poor metabolizer of amitriptyline Germline clinical trials Implication of APOE e1/e1 genotype - ineligible for clinical trial NCT03131453 Include an example of how a clinical trial match can be represented as a therapeutic implication.  Include SNOMED codes 444734003|Does not meet eligibility criteria for clinical trial (finding); 399223003|Patient eligible for clinical trial (finding) into the value set for the new 'predicted-therapeutic-implication' component. NOTE: FHIR-34277 will introduce a new extension that would allow referencing a "ResearchStudy" resource.
    • Arthur Herman / Bret Heale : 14-0-0
    • Enhancement
    • Non-substantive

    Description

      For a variety of our profiles, we should allow the delivery of 0..* possible clinical trial matches.

      Datatype could likely be RelatedArtifact

      Extension could be associated to just GenomicsReport for simplicity, or perhaps from any of our Observation profiles (findings or implications).

      We do have 'clinicaltrials.gov' as a code system today (http://hl7.org/fhir/R4/terminologies-systems.html)

      Attachments

        Activity

          People

            Unassigned Unassigned
            cerkyp Kevin Power
            Watchers:
            3 Start watching this issue

            Dates

              Created:
              Updated:
              Resolved: