Page History

Problem Statements

Tumors We started working on the TU/TR domains when this question was raised: if an abnormality can be considered as a lesion, should it be modeled using the TU/TR structure? This question came from modeling aneurysm data from the cardiovascular TA projects, where the aneurysm data were originally mapped to CV and discussions had taken place on whether it should be mapped to TU/TR. During our attempt to model the aneurysm and other related CV data to TU/TR, we noticed that: tumors are neoplastic lesions while an aneurysm is can be considered as a non-neoplastic, cardiovascular lesion. They all are considered as lesions, why is the modeling for the two types of lesions so different and inconsistent in TU?

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The results for TUTEST = Tumor Identification, are typically TUORRES = Target and Non-target. However results for this test can also be: BONE LESION, measurable/non-measurable, benign/malignant, new, etc. I We think the purpose of this test is to identify the “role” of a tumor, such as tumor type, malignancy status, measurability, etc. However, TU domain definition also states that TU is used to identify the location of the tumor. There is no specific TUTEST associated with the tumor location identification process - tumor locations are treated as a known fact and are mapped to TULOC directly for the Tumor Identification TUTEST. It isn't clear whether TUTEST = Tumor Identification, is also intended to be used to identify the location of the tumor.

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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 "Type" and "Location" identification is identifications are 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, this lesion may not be assigned a role (i.e. target) because said lesion will not undergo “assessment of disease response to therapy (i.e. RS)”. This lesion may be further classified based on severity, anatomy or other types of classifications 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.

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•  If all I need to do is to identify an objectthe type of a lesion, it’s location, characterize its physical properties (e.g. diameter measurement) and then evaluate its severity, there is no disease response to treatment data, in other words I have TU, maybe TR and CC data, but no TR and RS, can I use the TU? Show this example: https://wiki.cdisc.org/x/zxMiBw/TR structure?
•  How do we modeling model 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?
•  Lesion "Type" and "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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• Just because something can be considered as a lesion, should it be modeled in TU/TR? 

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Recommendations

1. Combining domains cause modeling inconsistencies. Oftentimes domains are created by different groups under different circumstances. The premises based on which a domain is built varies greatly for essentially, the same type of data (Tumor vs Non-tumor lesions). Because domains are governed by different teams (i.e. oncology and QRS SDS/CT teams), there are also different CT business rules developed for different domains.
   
2. May consider adding an assumption to better define "lesion" for TU: A localized pathological or traumatic structural change, damage, deformity, or discontinuity of tissue, organ, or body part (C3824). Anything that causes fundamental architectural changes to the structure is considered as a lesion. Jordan Li : ask Al and Nick to draft a better definition for lesion.
3. Consider updating the TUTEST = Tumor Identification to: Tumor "Role" Identification

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