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  1. There is a need to model whether or not a non-tumor lesion is identified in a region.
    1. This requires imaging location to be modeled in the TU domain.
    2. TU modeling needs to allow the creation of a “negative” record – I looked at this location but didn’t find what I suspected.
  2. Lesion "Location" identification is a separate process and test from "Role" identification. During the location identification process, the location for an identified lesion is a result qualifier. When this lesion undergoes "role" assessment, the location of the identified lesion is then a test qualifier.
  3. Once the location for a non-tumor lesion is identified, it this lesion may not always be assigned a role (i.e. target) because said lesion will not undergo “assessment of disease response to therapy (i.e. RS)”, it . This lesion may be further classified based on severity, anatomy or other types of classifications based on according to a published, validated public domain or copyrighted criteria. In this case, this should be modeled in the CC portion of the RS/CC combined domain.Results in TU are typically in the form of Target/Non-target, this is used to assign an identified tumor for subsequent assessment of disease response to treatment. This doesn't always happen for non-tumor lesion. To get around this issue: for the "where is it?" question for non-tumor lesions, suggesting a different TUTEST = XXX Location Identification, where TUORRES = Located.

The concept map below describes the modeling discrepancies between tumor and non-tumor lesions. Note the dotted lines and boxes indicate a step that didn't happen and data not modeled.

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  •  If all I need to do is to identify an object, it’s location, and then evaluate its severity, no disease response to treatment data, in other words I have TU and CC data, but no TR and RS, can I use TU? Show this example: https://wiki.cdisc.org/x/zxMiBw
  •  How do we modeling Result Location, when the result itself is the location? Should this be modeled in variables (RESLOC), or should we create tests for result location findings?
  •  "Location" identification should be modeled separately from "Role" Identification.
    •  To get around this issue: for the "where is it?" question for non-tumor lesions, suggesting a different TUTEST = XXX Location Identification, where TUORRES = Located.

CT Questions - The Non-Tumor Lesion Side

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