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Problem Statements

Tumors are neoplastic lesions while an aneurysm is 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?

TU/TR/RS were originally created for tumor identification and (tumor) disease assessment data. Non-tumor lesion modeling was later added onto TU/TR. RS was also combined with CC in either 2018 or 2019.

Arguments have been made that Tumor finding data modeling is prefaced on “already identified tumors”. TU records are created for each “identified tumor”, with the creation of a unique tumor ID (TULNKID). Since only already identified tumors are mapped to TU, this means, the locations (produced by imaging procedures) where one looked for the presence of a tumor and didn’t find it, is NOT modeled in TU.

  • This is in part due to the fact that imaging location is treated as a procedure attribute and is mapped to procedure.

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 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.

Identified tumors are considered to be target/non-target according to published criterion (e.g. RECIST) and this is to classify tumors for the subsequent assessment of disease response to treatment (RS).

This doesn’t work for non-tumor lesions, because:

  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, 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.

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.

TU Domain Modeling: Tumor vs Non-tumor Lesion Concept Map


Agreed Approaches so Far

  1. Imaging location should be treated as the TEST Location when identifying the location of a suspected object.
  2. We will not make changes to the tumor findings modeling in TU, several cancer TAUGs have been published and we do not want to cause backward compatibility issues.  We will only update the non-tumor lesions side.

Domain Level Questions

  • 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

  • On the tumor side, because you are only dealing with one type of lesion, you can get away with TUTEST = Tumor Identification. Use "tumor" as the beginning for all the identification tests. For non-tumor lesions, this convention is a bit odd. In the published CT I found: TUTEST = Cardiovascular Lesion Indicator, so is the expectation then to put the "type" of CV lesion in TULNKID? For example, TULNKID = Thoracic Aortic Aneurysm 1, where TUTEST = Cardiovascular Lesion Indicator? Alternative approach would be to pre-coordinate the suspected object into TUTEST, i.e. TUTEST = Aneurysm Lesion Indicator; TUTEST = Calcified Cardiac Annuls Indicator, etc.

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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